Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06894862




Registration number
NCT06894862
Ethics application status
Date submitted
9/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Study of the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants
Scientific title
A Phase I, Double-Blind, Placebo-Controlled, Randomised, First in Human, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants, When Administered as a 3-hour Infusion
Secondary ID [1] 0 0
NYR-BI03-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NYR-BI03
Treatment: Drugs - Matching placebo (all cohorts)

Experimental: NYR-BI03 intravenous infusion - NYR-BI03 administered in escalating doses as a continuous intravenous infusion over 3 hours

Placebo comparator: Placebo intravenous infusion - Placebo comparator administered as a continuous intravenous infusion over 3 hours


Treatment: Drugs: NYR-BI03
Participants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours.

Treatment: Drugs: Matching placebo (all cohorts)
Administered as a continuous intravenous infusion over 3 hours
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Related Adverse Events
Timepoint [1] 0 0
From enrollment up to and including follow-up assessments on Day 7
Secondary outcome [1] 0 0
Area under the plasma concentration versus time curve (AUC) of NYR-BI03
Timepoint [1] 0 0
From the start of the 3-hour infusion out to 48 hours (45 hours post the end of infusion). Pre-infusion, +30 minutes, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 48 hours
Secondary outcome [2] 0 0
Maximum observed blood concentration (Cmax) of NYR-BI03
Timepoint [2] 0 0
From the start of the 3-hour infusion out to 48 hours (45 hours post the end of infusion). Pre-infusion, +30 minutes, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 48 hours
Secondary outcome [3] 0 0
Tmax (time of occurrence of Cmax) of NYR-BI03
Timepoint [3] 0 0
From the start of the 3-hour infusion out to 48 hours (45 hours post the end of infusion). Pre-infusion, +30 minutes, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 48 hours
Secondary outcome [4] 0 0
Apparent terminal half-life (T1/2) of NYR-BI03
Timepoint [4] 0 0
From the start of the 3-hour infusion out to 48 hours (45 hours post the end of infusion). Pre-infusion, +30 minutes, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 48 hours
Secondary outcome [5] 0 0
Total body clearance from blood (CL) of NYR-BI03 calculated as Dose/AUC
Timepoint [5] 0 0
From the start of the 3-hour infusion out to 48 hours (45 hours post the end of infusion). Pre-infusion, +30 minutes, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 48 hours

Eligibility
Key inclusion criteria
* Male and Female
* 50.0 to 105.0 kg (inclusive)
* Body Mass Index (BMI) BMI of 18.0 to 30.0 kg/m2 (inclusive)
* General Health Healthy, determined by a medical history
* Contraceptive Status: Must agree to use of established highly effective contraception for the duration of the study and for at least 30 days thereafter
* Venous Access in their left and right arm to allow collection of blood samples and drug administration.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant females and lactating females are excluded from participating in the study.
* History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
* History of severe allergy or anaphylaxis.
* A known hypersensitivity to any surgical dressing which may be used
* History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, gynecological, ear, nose, and throat, or musculoskeletal disorders, psychiatric disorder or haematological disorders
* Any history of uncontrolled, severe asthma during the last 5 years
* A creatinine clearance of less than 80 mL/min
* Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product.
* History of abnormal bleeding tendencies, clotting disorders or thrombophlebitis unrelated to venipuncture or intravenous cannulation
* A positive test for hepatitis B surface antigen, a history of hepatitis C without a negative polymerase chain reaction (PCR) test, a history of HIV infection or demonstration of HIV antibodies
* Any evidence of organ dysfunction, or any clinically significant clinical laboratory value which, in the opinion of the Investigator would jeopardize the safety of the participant or impact on the validity of the study results,
* Liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) >1.5 x upper limit of normal
* Alcohol Use Those who may have difficulty abstaining from alcohol during the 48 hr prior to dose administration and until completion of the inpatient stay
* History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse
* Taking any prescription medications within 14 days prior to dose administration and/or likely to require prescription medication during the study
* Taking over-the-counter (OTC) medications or herbal supplements for 10 days prior to dose administration and/or likely to require or be unwilling to refrain from using OTC medications or herbal supplements during the study (with the exception of paracetamol, contraceptives, vitamin and other nutrient supplement use, at the discretion of the Investigator)
* Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g. coffee, tea, cola and chocolate) during the 24 hr prior to dose administration and whilst confined at the clinical study facility.
* Psychiatric Disorder History of any psychiatric illness which may impair the ability to provide written informed consent
* Protocol Compliance: Poor compliers or those unlikely to attend.
* Recent Study Participation Receipt of any drug as part of a research study within 30 days or 5 half-lives, whichever is longer, of initial dose administration in this study
* Standard blood donation within the 12-week period before dose administration
* Unusual dietary habits and excessive or unusual vitamin intakes
* Vaccination or immunizations within 30 days of initial dose administration
* Participants with a risk of QT/ corrected QT interval (QTc) prolongation, namely: a. A marked baseline prolongation of corrected QTcF interval >450 ms in males and >470 ms in females in two ECGs, or b. A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

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 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nyrada Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Argent, MD
Address 0 0
Scientia Clinical Research Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexandra Suchowerska, PhD
Address 0 0
Country 0 0
Phone 0 0
(+61) 425-250-526
Fax 0 0
Email 0 0
[email protected]
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/NCT06894862