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

Registration

Registration

NCT05893043

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

COMPLETED

Enrollment

18

Start

2023-04-24

Primary completion

2023-06-28

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Conditions

Healthy Volunteers

Interventions

DRUG:GSBR-1290; OTHER:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Number of Participants With Adverse Events (AEs) and Serious AEs [From start of study drug up to End of study (EOS) (up to Day 42)]
• Number of Participants Based on Severity of AEs [From start of study drug up to EOS (up to Day 42)]
• Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Baseline up to EOS (Day 42)]
• Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [Baseline up to EOS (Day 42)]
• Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [Baseline up to EOS (Day 42)]