NCT05893043

A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess safety and tolerability of multiple oral doses of GSBR-1290 (capsule) in healthy adult Japanese participants compared to non-Japanese participants.

Detailed description

This is a multiple ascending dose (MAD) study in which 4 dose levels will be evaluated in 2 cohorts from Day 1 to Day 28 (4-week period). The starting dose of GSBR-1290 will be based on results from the single ascending dose (SAD) study (GSBR-1290-01) and MAD study (GSBR-1290-02 \[NCT05762471\]).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GSBR-1290	Participants will receive GSBR-1290 oral capsules.
OTHER	Placebo	Participants will receive matching placebo oral capsules.

Timeline

• Start date: 2023-04-24
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2023-06-07
• Last updated: 2023-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study