A Study of the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants

NCT06894862 | Completed Phase 1

• 1 other identifier: NYR-BI03-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 study will also show what if any medical problems participants have when taking drug NYR-BI03 and it will provide information on blood levels of the drug. Researchers will compare drug NYR-BI03 to a placebo (a similar substance that contains no drug) to see if NYR-BI03 is safe and tolerated. Participants will be administered drug NYR-BI03 or a placebo via intravenous infusion for up to 6 hours and be assessed by physical examination and laboratory tests.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  The safety and tolerability of NYR-BI03 in healthy volunteers, when administered as a 3 hour or 6 hour intravenous (IV) infusion.

  From enrollment up to and including follow-up assessments on Day 7

Secondary Outcomes (5)

• Area under the plasma concentration versus time curve (AUC) of NYR-BI03

  For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.

• Maximum observed blood concentration (Cmax) of NYR-BI03

  For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.

• Tmax (time of occurrence of Cmax) of NYR-BI03

  For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.

• Apparent terminal half-life (T1/2) of NYR-BI03

  For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.

• Total body clearance from blood (CL) of NYR-BI03 calculated as Dose/AUC

  For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.

Study Arms (2)

NYR-BI03 intravenous infusion

EXPERIMENTAL

NYR-BI03 administered in escalating doses as a continuous intravenous infusion for up to 6 hours

Drug: NYR-BI03

Placebo intravenous infusion

PLACEBO COMPARATOR

Placebo comparator administered as a continuous intravenous infusion for up to 6 hours

Drug: Matching placebo (all cohorts)

Interventions

NYR-BI03 DRUG

Participants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours or 6 hours.

Also known as: Xolatryp

NYR-BI03 intravenous infusion

Matching placebo (all cohorts) DRUG

Administered as a continuous intravenous infusion over 3 hours or 6 hours

Placebo intravenous infusion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Cisgender males Cisgender females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nyrada Pty Ltd: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

Study Officials

• Christopher Argent, MD

  Scientia Clinical Research Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted double blinded. Authorised unblinded study staff will be clearly designated and documented and are not permitted to perform any study assessments or have contact with participants for data collection after the first dose of study product. An unblinded pharmacist will prepare the study products and strict procedures will be implemented to ensure that only designated unblinded study staff have access to the randomized treatment allocation for each participant.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Groups of participants are assigned to receive either NYR-BI03 or placebo in a 6:2 ratio (n=8 per cohort). Participants receiving the placebo will be pooled. Doses are escalated in five groups/cohorts, subject to safety review by the Safety Review Committee.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 25, 2025
• Study Start: March 19, 2025
• Primary Completion: July 24, 2025
• Study Completion: July 25, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available 12 months after publication of primary results and remain accessible for at least 5 years.
• Access Criteria: Data access requests will be evaluated by an independent Data Access Committee. Applicants must submit a research proposal and evidence of ethics approval, and, if approved, sign a data use agreement that restricts use to the proposed research and prohibits re-identification. Data will be hosted in a secure repository. For inquiries, please contact Dr Alexandra Suchowerska at alexandra.suchowerska@nyrada.com

Locations

AU (1)