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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: GSBR-1290; Other: Placebo

• Registration Number: NCT05893043
• Lead Sponsor: Gasherbrum Bio, Inc

Brief 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 \[NCT05762471\]).

Study Timeline

• Study Start: 2023-04-24
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-07
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: GSBR-1290 or Placebo	Placebo	Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.
Cohort 1: GSBR-1290 or Placebo	GSBR-1290	Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.
Cohort 2: GSBR-1290	GSBR-1290	Healthy non-Japanese participants (Caucasians or African Americans) will receive once daily doses of study drug (GSBR-1290 oral capsules) for up to 4 weeks.

Primary Outcome Measures

Name	Time	Method
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 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 Laboratory Parameters	Baseline up to EOS (Day 42)

Secondary Outcome Measures

Name	Time	Method
Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters	31 days
Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters	31 days
Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters	31 days
Analysis of Area Under the Plasma Concentration-time Curve (AUC) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters	31 days

Trial Locations

Locations (1)

ACT; 🇺🇸 Anaheim, California, United States