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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05893043

Run by

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

People needed

18

Starts

2023-04-24

Expected to finish

2023-06-28

Last updated by the study team

2023-07-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For Cohort 1 only:
• Japanese participants must have both parents and 4 grandparents of Japanese origin
• For Cohort 2 only:
• Non-Japanese participants must not have parents and grandparents of Japanese origin. Non-Japanese participants will be limited to Caucasians of European and Latin American descent or African Americans
• For Cohorts 1 and 2:
• Must have given written informed consent before any study-related activities are carried out
• Adult males and females, age 18 to 55 years of age (inclusive) at screening
• Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 24.9 kilogram per square meter (kg/m\^2), with a body weight (to 1 decimal place) >= 45.0 kg at screening
• No nicotine use
• Sitting blood pressure after resting for 5 minutes between 90 to 140 millimeter of mercury (mm Hg) systolic and 50 to 90 mm Hg diastolic and a heart rate between 40 to 100 beats per minute
• Have suitable venous access for blood sampling

You may not qualify if…

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
• Liver function test results elevated > 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
• Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m\^2 body surface area
• Known hypersensitivity to any of the study drug ingredients
• Any other condition or prior therapy that would make the participant unsuitable for this study

Where it is running

• ACT — Anaheim, California, United States

Full record on ClinicalTrials.gov

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