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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03493191




Registration number
NCT03493191
Ethics application status
Date submitted
26/03/2018
Date registered
10/04/2018
Date last updated
26/02/2019

Titles & IDs
Public title
A Single Dose Study of SHR0410 in Healthy Male Participants
Scientific title
A Phase I, Randomized, Double-blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SHR0410 in Healthy Male Participants
Secondary ID [1] 0 0
SHR0410-101-AU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.5µg/kg SHR0410
Treatment: Drugs - 1µg/kg SHR0410
Treatment: Drugs - 2µg/kg SHR0410
Treatment: Drugs - 5µg/kg SHR0410
Treatment: Drugs - 10µg/kg SHR0410
Treatment: Drugs - 20µg/kg SHR0410

Experimental: 0.5 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 0.5µg/kg SHR0410 (n=6) or placebo (n=2)

Experimental: 1 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 1µg/kg SHR0410 (n=6) or placebo (n=2)

Experimental: 2 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 2µg/kg SHR0410 (n=6) or placebo (n=2)

Experimental: 5 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 5µg/kg SHR0410 (n=6) or placebo (n=2)

Experimental: 10 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10µg/kg SHR0410 (n=6) or placebo (n=2)

Experimental: 20 µg/kg SHR0410 - 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10µg/kg SHR0410 (n=6) or placebo (n=2)


Treatment: Drugs: 0.5µg/kg SHR0410
a single dose of 0.5µg/kg SHR0410

Treatment: Drugs: 1µg/kg SHR0410
a single dose of 2µg/kg SHR0410

Treatment: Drugs: 2µg/kg SHR0410
a single dose of 2µg/kg SHR0410

Treatment: Drugs: 5µg/kg SHR0410
a single dose of 5µg/kg SHR0410

Treatment: Drugs: 10µg/kg SHR0410
a single dose of 10µg/kg SHR0410

Treatment: Drugs: 20µg/kg SHR0410
a single dose of 20µg/kg SHR0410
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse events in terms of changes in Hematology
Assessment method [1] 0 0
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Timepoint [1] 0 0
Up to Day 8
Primary outcome [2] 0 0
Incidence of Adverse events in terms of changes in Urinalysis
Assessment method [2] 0 0
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Timepoint [2] 0 0
Up to Day 8
Primary outcome [3] 0 0
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Assessment method [3] 0 0
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Timepoint [3] 0 0
Up to Day 8
Primary outcome [4] 0 0
Incidence of Adverse events in terms of changes in Physical examinations
Assessment method [4] 0 0
Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities
Timepoint [4] 0 0
Up to Day 8
Primary outcome [5] 0 0
Incidence of Adverse events in terms of changes in Vital signs
Assessment method [5] 0 0
Oral temperature, respiratory rate, blood pressure, and pulse rate
Timepoint [5] 0 0
Up to Day 8
Primary outcome [6] 0 0
Incidence of Adverse events in terms of changes in 12-lead ECGs
Assessment method [6] 0 0
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
Timepoint [6] 0 0
Up to Day 8
Secondary outcome [1] 0 0
Area under the plasma concentration versus time curve (AUC)
Assessment method [1] 0 0
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Timepoint [1] 0 0
Up to 24 hours post dose
Secondary outcome [2] 0 0
Time to the peak plasma concentration (Tmax)
Assessment method [2] 0 0
Time to Maximum Plasma SHR0410 Concentration
Timepoint [2] 0 0
Up to 24 hours post dose
Secondary outcome [3] 0 0
Peak Plasma Concentration (Cmax)
Assessment method [3] 0 0
Peak Plasma SHR0410 Concentration
Timepoint [3] 0 0
Up to 24 hours post dose
Secondary outcome [4] 0 0
Half-time (T1/2)
Assessment method [4] 0 0
Half-time of SHR0410
Timepoint [4] 0 0
Up to 24 hours post dose
Secondary outcome [5] 0 0
Urine output rate
Assessment method [5] 0 0
Changes in urine output rate from baseline
Timepoint [5] 0 0
Up to 48 hours post dose
Secondary outcome [6] 0 0
Serum prolactin release rate
Assessment method [6] 0 0
Changes in serum prolactin release rate from baseline
Timepoint [6] 0 0
Up to 48 hours post dose

Eligibility
Key inclusion criteria
1. Male between the ages of 18 and 45 years, inclusive.
2. Body mass index (BMI) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive.
3. Considered generally healthy upon completion of medical history, physical examination, vital signs, SpO2, laboratory parameters, and ECG, as judged by the Investigator.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known sensitivity to any of the components of the investigational product formulation, or any other opioids.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
3. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.

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 analysing the results/data
Intervention assignment
Parallel
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
15/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2018
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Linear Clinical Research
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT03493191