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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gasherbrum Bio, Inc

Criteria

Inclusion Criteria:

For Cohort 1 only:

1. Japanese participants must have both parents and 4 grandparents of Japanese origin

For Cohort 2 only:

2. 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:

3. Must have given written informed consent before any study-related activities are carried out

4. Adult males and females, age 18 to 55 years of age (inclusive) at screening

5. 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

6. No nicotine use

7. 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

8. Have suitable venous access for blood sampling

Exclusion Criteria:

1. 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

2. 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

3. Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m^2 body surface area

4. Known hypersensitivity to any of the study drug ingredients

5. Any other condition or prior therapy that would make the participant unsuitable for this study