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

NCT06894862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nyrada Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Christopher Argent, MD · Scientia Clinical Research Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2025-07-24
Completion
2025-07-25

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894862 on ClinicalTrials.gov