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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05033444




Registration number
NCT05033444
Ethics application status
Date submitted
12/08/2021
Date registered
2/09/2021
Date last updated
4/11/2024

Titles & IDs
Public title
A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers.
Secondary ID [1] 0 0
PRV-002-AUU-01
Secondary ID [2] 0 0
PRV-002-AU-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRV-002
Treatment: Drugs - Placebo

Experimental: PRV-002 - PRV-002 active formulation

Placebo comparator: Placebo comparator - Placebo used is hydroxypropyl beta cyclodextrin (HPßCD)


Treatment: Drugs: PRV-002
SAD portion: Eligible participants will be randomized to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomized to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.533 mg/kg (based on a 60kg participant) will be investigated.

MAD portion: Eligible participants will be randomized to receive a multiple (one dose per day for 5 consecutive days). Dose escalation will be conducted in a total of 2 cohorts. Within each cohort, 6 participants will be randomized to receive of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.266 mg/kg (based on a 60kg participant) will be investigated.

Treatment: Drugs: Placebo
Placebo used is hydroxypropyl beta cyclodextrin (HPßCD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)).
Assessment method [1] 0 0
AEs/SAEs (or ADEs/SADEs) to be recorded as written descriptions on case report forms
Timepoint [1] 0 0
Baseline pre-intervention (Day -28 to Day -2 and Day -1); during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
Primary outcome [2] 0 0
Safety endpoint - Change from baseline in physical examination findings (Full)
Assessment method [2] 0 0
Full physical exam including general appearance, head, ears, eyes, nose and throat, neck (including thyroid and lymph nodes), respiratory system, cardiovascular system, gastrointestinal system, renal system, neurological condition, musculoskeletal system, skin and any other focused assessments suggested by the presence of specific symptoms and measured by written descriptions.
Timepoint [2] 0 0
Baseline pre-intervention Day -28 to -2.
Primary outcome [3] 0 0
Safety endpoint - Change from baseline in physical examination findings (symptom directed)
Assessment method [3] 0 0
Symptom-directed physical examination (focused assessments suggested by the presence of specific symptoms) will be performed if clinically indicated, as determined by the Investigator. The pre-dose physical examination assessment should be performed on the scheduled day, at any time prior to dosing. All other physical examinations will be performed within ± 1 hour of the nominated timepoint. Measured by written descriptions.
Timepoint [3] 0 0
Baseline pre-intervention Day -1 and and Day 1; Day 2
Primary outcome [4] 0 0
Safety endpoint - Change from baseline in vital signs (including changes from baseline in SpO2).
Assessment method [4] 0 0
SpO2 measured as percent of oxygen (%)
Timepoint [4] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [5] 0 0
Safety endpoint - Change from baseline in vital signs (including changes from baseline in blood pressure).
Assessment method [5] 0 0
Blood pressure measured for systolic and diastolic pressure as mm of mercury.
Timepoint [5] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [6] 0 0
Safety endpoint - Change from baseline in vital signs (including changes from baseline in heart rate).
Assessment method [6] 0 0
Heart rate measured as beats per minute (BPM)
Timepoint [6] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [7] 0 0
Safety endpoint - Change from baseline in vital signs (including changes from baseline in respiration rate).
Assessment method [7] 0 0
Respiration rate measured as breaths per minute
Timepoint [7] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [8] 0 0
Safety endpoint - Change from baseline in vital signs (including changes from baseline in body temperature).
Assessment method [8] 0 0
Body temperature measured as degrees Celsius (C)
Timepoint [8] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [9] 0 0
Safety endpoint - Changes from baseline in lung spirometry.
Assessment method [9] 0 0
Lung spirometry measured as the ratio of forced expiratory value (FEV1)/ forced vital capacity (FVC) and reported as percentage (%)
Timepoint [9] 0 0
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.25hr, 1hr, 10hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [10] 0 0
Safety endpoint - Change from baseline in ECG parameters of heart rate
Assessment method [10] 0 0
Heart ratel measured beats per minute (BPM)
Timepoint [10] 0 0
Baseline pre-intervention; during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
Primary outcome [11] 0 0
Safety endpoint - Change from baseline in ECG parameters of PR interval, QRS interval, and QT interval
Assessment method [11] 0 0
PR interval, QRS interval, and QT interval as measured in milliseconds (ms)
Timepoint [11] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 pre-intervention; Day 1 at 0.5hr, 2hr, 6hr; 12hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [12] 0 0
Safety endpoint - Change from baseline in hematocrit values
Assessment method [12] 0 0
Hematocrit measured as the percentage of red blood cells in whole blood (%)
Timepoint [12] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [13] 0 0
Safety endpoint - Change from baseline in hemoglobin values
Assessment method [13] 0 0
Hemoglobin measured as the amount of hemoglobin in whole blood measured as grams per deciliter (g/dL)
Timepoint [13] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [14] 0 0
Safety endpoint - Change from baseline in Red Blood Cell (RBC) indices
Assessment method [14] 0 0
RBC measured as the number of million RBCs per microliter (mcL) of blood
Timepoint [14] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [15] 0 0
Safety endpoint - Change from baseline in Thrombocyte Count (Platelets); White Blood Cells (WBC); Basophils; Eosinophils; Lymphocytes; Monocytes; and Neutrophils.
Assessment method [15] 0 0
Platelets measured as the number of cells per microliter (mcL) of blood
Timepoint [15] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [16] 0 0
Safety endpoint - Change from baseline in the blood hormone level of Dehydroepiandrosterone-sulfate (DHEAS)
Assessment method [16] 0 0
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (µg/dL) of blood
Timepoint [16] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [17] 0 0
Safety endpoint - Change from baseline in the blood hormone level of dihydrotestosterone (DHT)
Assessment method [17] 0 0
Dihydrotestosterone (DHT) measured as the number of nano moles per liter (nmol/L) of blood
Timepoint [17] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [18] 0 0
Safety endpoint - Change from baseline in the blood hormone level of luteinizing hormone (LH)
Assessment method [18] 0 0
Luteinizing hormone (LH) measured as the number of International units per liter (IU/L)
Timepoint [18] 0 0
Baseline pre-intervention Days -28 to -2
Primary outcome [19] 0 0
Safety endpoint - Change from baseline in the blood hormone level of dehydroepiandrosterone sulfate (DHEAS)
Assessment method [19] 0 0
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (mcg/dL)
Timepoint [19] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [20] 0 0
Safety endpoint - Change from baseline in the blood hormone level of thyroid stimulating hormone (TSH)
Assessment method [20] 0 0
Thyroid stimulating hormone (TSH) measured as the number of milli-international units per liter (mIU/L)
Timepoint [20] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [21] 0 0
Safety endpoint - For postmenopausal women only, change from baseline in the blood hormone level of follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH)
Assessment method [21] 0 0
Follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH) measured as the number of milli-international units per milliliter (mIU/mL)
Timepoint [21] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [22] 0 0
Safety endpoint - Change from baseline in the blood hormone level of free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT)
Assessment method [22] 0 0
Free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT) measured as the number of nanograms per deciliter (ng/dL)
Timepoint [22] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [23] 0 0
Safety endpoint - Change from baseline in the blood hormone level of progesterone
Assessment method [23] 0 0
Progesterone measured as the number of nanograms per miiliiliter (ng/mL)
Timepoint [23] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [24] 0 0
Safety endpoint - Change from baseline in the blood hormone level of estradiol (E2) and free trilodothyronine (FT3)
Assessment method [24] 0 0
Estradiol (E2) and free trilodothyronine (FT3) measured as the number of picograms per milliliter (pg/mL)
Timepoint [24] 0 0
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Primary outcome [25] 0 0
Safety endpoint Change in baseline in clotting factors Partial thromboplastin time (aPTT) and Prothrombin time (PT)
Assessment method [25] 0 0
Partial thromboplastin time (aPTT) and Prothrombin time (PT) measured as time to clot in seconds (sec)
Timepoint [25] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [26] 0 0
Safety endpoint - Change from baseline in the clotting factor Fibrinogen
Assessment method [26] 0 0
Fibrinogen measured as the number of milligrams per deciliter (mg/dL)
Timepoint [26] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [27] 0 0
Safety endpoint - Change from baseline in the clotting factor International Normalized Ratio (INR)
Assessment method [27] 0 0
International Normalized Ratio (INR) measured as the ratio of patient PT/control PT
Timepoint [27] 0 0
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Primary outcome [28] 0 0
Safety endpoint - Change from baseline in urinalysis parameters bilirubin, blood, glucose, nitrites, protein, and urobilinogen
Assessment method [28] 0 0
Bilirubin, blood, glucose, nitrites, protein, and urobilinogen measured as the number of milligrams per deciliter (mg/dL)
Timepoint [28] 0 0
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Primary outcome [29] 0 0
Safety endpoint - Change from baseline in urinalysis parameter ketones
Assessment method [29] 0 0
Ketones measured as the number of millimoles per liter (mmol/L)
Timepoint [29] 0 0
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Primary outcome [30] 0 0
Safety endpoint - Change from baseline in urinalysis parameter leukocyte esterase
Assessment method [30] 0 0
Leukocyte esterase measured as negative or positive; number of WBCs per high power field
Timepoint [30] 0 0
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Primary outcome [31] 0 0
Safety endpoint - Change from baseline in urinalysis parameter pH
Assessment method [31] 0 0
pH measured as pH units
Timepoint [31] 0 0
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Primary outcome [32] 0 0
Safety endpoint - Change from baseline in urinalysis parameter specific gravity
Assessment method [32] 0 0
Specific gravity measured as specific gravity units as a ratio of density of urine/density of water
Timepoint [32] 0 0
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Primary outcome [33] 0 0
Safety endpoint - Change from baseline in serum chemistry parameters globulin, protein, and albumin
Assessment method [33] 0 0
Globulin, protein, and albumin measured as grams per deciliter (g/dL)
Timepoint [33] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [34] 0 0
Safety endpoint - Change from baseline in serum chemistry parameter alkaline phosphatase
Assessment method [34] 0 0
Alkaline phosphatase measured as International units per liter (IU/L)
Timepoint [34] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [35] 0 0
Safety endpoint - Change from baseline in serum chemistry parameters bicarbonate, chloride, sodium, and magnesium
Assessment method [35] 0 0
Bicarbonate, chloride, sodium, and magnesium measured as milliequivalents per liter (mEq/L)
Timepoint [35] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [36] 0 0
Safety endpoint - Change from baseline in serum calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol
Assessment method [36] 0 0
Calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol, triglycerides measured as milligrams per deciliter (mg/dL)
Timepoint [36] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [37] 0 0
Safety endpoint - Change from baseline in serum chemistry parameters potassium
Assessment method [37] 0 0
Potassium measured as millimoles per liter (mmol/L)
Timepoint [37] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [38] 0 0
Safety endpoint - Change from baseline in serum chemistry parameters lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase
Assessment method [38] 0 0
Lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase measured as Units per liter (U/L)
Timepoint [38] 0 0
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Primary outcome [39] 0 0
Safety endpoint - Change from baseline in virology parameters HIV-1/-2; HBsAg; HCV; SARS-COV-2
Assessment method [39] 0 0
HIV-1/-2; HBsAg; HCV; SARS-COV-2 test results measured as negative or positive
Timepoint [39] 0 0
Baseline pre-intervention Day -28 to -2
Primary outcome [40] 0 0
Safety endpoint - Change from baseline in drug screen findings for alcohol
Assessment method [40] 0 0
Alcohol test results measured as percentage (%)
Timepoint [40] 0 0
Baseline pre-intervention Day -28 to -2; Day -1
Primary outcome [41] 0 0
Safety endpoint - Change from baseline in urine drug screen findings for amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants
Assessment method [41] 0 0
Urine amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants test results measured as nanograms per milliliter (ng/mL)
Timepoint [41] 0 0
Baseline pre-intervention Day -28 to -2; Day -1
Primary outcome [42] 0 0
Safety endpoint - Change from baseline for pregnancy test for serum hCG and urine hCG
Assessment method [42] 0 0
Serum hCG and Urine hCG levels measured in milli-international units per liter (mIU/L)
Timepoint [42] 0 0
Serum pregnancy test Days -28 to -2 and on Day 5; Urine pregnancy test Day -1
Primary outcome [43] 0 0
Safety endpoint - Change from baseline for confirmation of postmenopausal status test for FSH
Assessment method [43] 0 0
FSH levels measured in milli-international units per liter (mIU/L)
Timepoint [43] 0 0
Baseline pre-intervention on Days -28 to -2
Secondary outcome [1] 0 0
Plasma pharmacokinetics - Cmax
Assessment method [1] 0 0
Plasma PRV-002 Cmax measured as microgram per mL (mcg/mL)
Timepoint [1] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [2] 0 0
Plasma pharmacokinetics - Tmax
Assessment method [2] 0 0
Plasma PRV-002 time to Cmax
Timepoint [2] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [3] 0 0
Plasma pharmacokinetics - area under the curve
Assessment method [3] 0 0
Plasma PRV-002 Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUC0-t) measured as min\*kBq/mL
Timepoint [3] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [4] 0 0
Plasma pharmacokinetics - area under the concentration-time curve
Assessment method [4] 0 0
Plasma PRV-002 area under the concentration-time curve from 0 to infinity (AUC0-inf) measured as mg\*h/L
Timepoint [4] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [5] 0 0
Plasma pharmacokinetics - apparent terminal elimination half-life t1/2)
Assessment method [5] 0 0
Plasma PRV-002 apparent terminal elimination half-life (t1/2) measured in minutes or hours
Timepoint [5] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [6] 0 0
Plasma pharmacokinetics - terminal elimination rate constant (?z)
Assessment method [6] 0 0
Plasma PRV-002 terminal elimination rate constant (?z) measured as elimination rate measured as constant K or Ke ((?z))
Timepoint [6] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [7] 0 0
Plasma pharmacokinetics total apparent body clearance
Assessment method [7] 0 0
Plasma PRV-002 total apparent body clearance measured as (CL/F)
Timepoint [7] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [8] 0 0
Plasma pharmacokinetics - apparent volume of distribution
Assessment method [8] 0 0
Plasma PRV-002 apparent volume of distribution measured as (Vz/F)
Timepoint [8] 0 0
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Secondary outcome [9] 0 0
Urine pharmacokinetics - cumulative amount of unchanged drug excreted in urine
Assessment method [9] 0 0
Urine PRV-002 cumulative amount of unchanged drug excreted (Ae) in urine measured in micrograms per milliliter (mcg/mL)
Timepoint [9] 0 0
Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.
Secondary outcome [10] 0 0
Urine pharmacokinetics - renal clearance
Assessment method [10] 0 0
Urine PRV-002 renal clearance measured as (CLr)
Timepoint [10] 0 0
Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.

Eligibility
Key inclusion criteria
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. Body mass index (BMI) = 18.0 and = 30.0 kg/m2, with a body weight (to 1 decimal place) = 50 kg at screening.
4. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration.
5. Have a negative test for cotinine at the screening visit and at check-in on Day -1.
6. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit in the Schedules of

Assessments (SoA), including:
1. Physical examination without any clinically significant findings
2. Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
3. Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
4. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
5. No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests
6. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF = 450 msec for males and = 470 msec for females and no clinically significant abnormalities
7. Pulmonary assessments must be within the normal range (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio = 80% of normal values; f forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted)
8. Oxygen saturation (SpO2) monitor = 95%.
7. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the timepoints indicated in the Schedules of Assessments (SoA), including:

1. Physical examination without any clinically significant findings
2. Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
3. Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
4. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
5. No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests
6. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF = 450 msec for males and = 470 msec for females and no clinically significant abnormalities
7. Pulmonary assessments must be within the normal range (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio = 80% of normal values; f forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted)
8. Oxygen saturation (SpO2) monitor = 95%.
8. Female volunteers must:

1. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause
2. Have a follicle-stimulating hormone level >40 IU/L at the screening visit),or
3. If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
9. Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
10. Have suitable venous access for blood sampling.
11. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

-
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular disease
2. History or presence of significant pulmonary disease
3. History or presence of significant hepatic disease
4. History or presence of significant renal disease
5. History or presence of significant haematological disease
6. History or presence of significant gastrointestinal disease
7. History or presence of significant disease
8. History or presence of significant endocrine disease
9. History or presence of significant immunologic disease
10. History or presence of significant dermatologic disease
11. History or presence of significant or neurological disease
12. No major surgery within the past 3 months determined by the PI to be clinically significant.
13. Absence of any acute illness.
14. Current infection that requires systemically absorbed antibiotic.
15. Current infection that requires systemically absorbed antifungal.
16. Current infection that requires systemically absorbed antiparasitic.
17. Current infection that requires systemically absorbed antiviral medication.
18. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
19. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
20. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration.
21. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death).
22. Known arrythmia
23. Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
24. Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase
25. Liver function test results elevated more than 1.5-fold above the ULN for bilirubin (total)
26. Liver function test results elevated more than 1.5-fold above the ULN for bilirubin (conjugated)
27. Liver function test results elevated more than 1.5-fold above the ULN for ALP. Volunteers with ALP above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
28. Liver function test results elevated more than 1.5-fold above the ULN for AST. Volunteers with AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
29. Liver function test results elevated more than 1.5-fold above the ULN for ALT. Volunteers with ALT above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
30. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2) antibodies at the screening visit.
31. Positive test results for active hepatitis B surface antigen (HBsAg) antibodies at the screening visit.
32. Positive test results for active hepatitis C virus (HCV) antibodies at the screening visit.
33. Presence or having sequelae of known to interfere with the absorption, distribution, metabolism, or excretion of drugs such as gastrointestinal, liver, kidney, or other conditions .
34. Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
35. History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
36. Positive drugs of abuse at the screening visit.
37. Positive drugs of abuse at check-in (Day -1).
38. Positive alcohol breath test results at the screening visit.
39. Positive alcohol breath test results at check-in (Day -1).
40. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days prior to the first study drug administration, - exceptions include use of contraceptives, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days), ibuprofen (doses of 400 mg up to every 6 hours or 1.6 g per day maximum for no more than 3 consecutive days), topical ointments, and vitamins or dietary supplements.
41. Consumption of grapefruit or Seville orange (or products containing grapefruit or Seville orange) within 10 days prior to the first administration of study drug.
42. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
43. Known hypersensitivity to any of the study drug ingredients.
44. Use of any vaccinations within 14 days prior to the first study drug administration.
45. For women of childbearing potential, a positive serum pregnancy test at the screening visit.
46. For women of childbearing potential, a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
47. Females who are breastfeeding or planning to breast feed at any time during the study.
48. Donation of blood or plasma within 30 days prior to first study drug administration.
49. Loss of whole blood of more than 500 mL within 30 days prior to first study drug administration.
50. Receipt of a blood transfusion within 1 year of first study drug administration.
51. Participation in another clinical trial of an investigational drug within 60 days of the first study drug administration.
52. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

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Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2024
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd, - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Odyssey Group International, Inc.
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, Dr.
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mike Lewandowski, BS
Address 0 0
Country 0 0
Phone 0 0
7276926196
Email 0 0
mlewandowski@odysseygi.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05033444