Status:
COMPLETED
A Study of the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants
Lead Sponsor:
Nyrada Pty Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to learn if investigational drug NYR-BI03 is safe and tolerated when given as an intravenous infusion for up to 6 hours to healthy male and female volunteers. The s...
Detailed Description
The study is a Phase 1, double-blind, randomised, first-in-human, dose escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of NYR-BI03 when administered as an intravenous (I...
Eligibility Criteria
Inclusion
- Male and Female
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06894862
Start Date
March 19 2025
End Date
July 25 2025
Last Update
July 29 2025
Active Locations (1)
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1
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031