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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05893043
• Other study ID #: GSBR-1290-03
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2023
• Est. completion date: June 28, 2023

Study information

• Verified date: July 2023
• Source: Gasherbrum Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GSBR-1290
Participants will receive GSBR-1290 oral capsules.

Other:
• Placebo
Participants will receive matching placebo oral capsules.

Locations

Country	Name	City	State
United States	ACT	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Gasherbrum Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of Participants Based on Severity of AEs		From start of study drug up to EOS (up to Day 42)
Primary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs		Baseline up to EOS (Day 42)
Primary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters		Baseline up to EOS (Day 42)
Primary	Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters		Baseline up to EOS (Day 42)
Secondary	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
Secondary	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
Secondary	Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters		31 days
Secondary	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