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

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.

Timeline

Start

2025-03-19

Primary completion

2025-07-24

Completion

2025-07-25

Outcome

Met primary endpoint

release “Key Results: Xolatryp met its Primary Endpoint with all doses safe and well tolerated, with no dose-limiting, or dose-related safety issues.” nyrada.com ↗

Drugs

Indications

No indication recorded.