Testing the safety and tolerability of NYR-BI03 in healthy volunteers

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

This study is testing a new drug called NYR-BI03 to see if it's safe and tolerable for healthy volunteers when given through an IV.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Nyrada Pty Ltd (Industry-sponsored)
• Locations: 1 site (Randwick, New South Wales)
• Trial ID: NCT06894862 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, and pharmacokinetics of the investigational drug NYR-BI03 administered as an intravenous infusion over three hours to healthy participants. The study is designed as a Phase 1, double-blind, randomized, first-in-human trial with five ascending dose cohorts, enrolling up to 40 participants. Each participant will receive either the active drug or a placebo, followed by thorough safety assessments and blood sample collections to monitor drug levels. Participants will be monitored for adverse events and undergo various laboratory tests to ensure their health and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male and female adults aged between 50.0 to 105.0 kg with a BMI of 18.0 to 30.0 kg/m2.

Not a fit: Patients who are pregnant, lactating, or have a history of significant allergies or medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and tolerability of NYR-BI03, paving the way for its potential use in future treatments.

How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug NYR-BI03 is novel and has not been previously tested in humans.

Eligibility criteria

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.

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).

Where this trial is running

Randwick, New South Wales

• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Christopher Argent, MD — Scientia Clinical Research Ltd
• Study coordinator: Alexandra Suchowerska, PhD

Conditions Healthy