NCT06894862

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

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 an Infusion for up to 6 Hours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nyrada Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 (IV) infusion for up to 6 hours to healthy participants. Six (6) ascending dose cohorts are planned. Up to 48 participants will be enrolled sequentially into the cohorts, with a total of 8 participants per cohort (6 active, 2 placebo). Each participant will be screened within a 28-day screening period after providing voluntary, written informed consent. If eligible, participants will be admitted to the clinical unit on Day -1 for confinement and randomised to be administered a single IV dose of NYR-BI03 or placebo for up to 6 hours on Day 1. After confinement for at least 48 hours after the start of infusion for safety assessments and collection of PK blood samples, participants will be discharged from the clinical unit on Day 3. Participants will return to the clinical unit for the End of Study visit (EOS) on Day 7 for final safety monitoring. Safety assessments will include collection of adverse events (AEs), laboratory tests (hematology, biochemistry, coagulation, urinalysis), physical examination, basic neurological examination, pupillary response assessment, vital signs, cardiac telemetry, and 12-lead electrocardiogram (ECG). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed at least 24 hours before the rest of the cohort. Blinded safety and tolerability data from the sentinel group up to and including 24 hours post-dose (i.e., up to and including the Day 2 assessments) will be reviewed by the Principal Investigator, with provision for additional review if deemed necessary. Following a satisfactory safety review, dosing of the rest of the cohort may proceed. After each completed dose cohort, the Safety Review Committee (SRC) will review the available cumulative blinded safety data and available blinded PK data.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	NYR-BI03	Participants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours or 6 hours.
DRUG	Matching placebo (all cohorts)	Administered as a continuous intravenous infusion over 3 hours or 6 hours

Timeline

• Start date: 2025-03-19
• Primary completion: 2025-07-24
• Completion: 2025-07-25
• First posted: 2025-03-25
• Last updated: 2025-07-29

Locations

1 site across 1 country: Australia