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

• Sponsor: Gasherbrum Bio, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05893043
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GSBR-1290; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Study drug (GSBR-1290 or placebo) administration in Cohort 1 is double-blind and Study drug (GSBR-1290) administration in Cohort 2 is open label.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 24, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: GSBR-1290 or Placebo Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.	Drug: GSBR-1290; Participants will receive GSBR-1290 oral capsules.; Other Names: GSBR-1001290 ; Other: Placebo; Participants will receive matching placebo oral capsules.
Experimental: Cohort 2: 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.	Drug: GSBR-1290; Participants will receive GSBR-1290 oral capsules.; Other Names: GSBR-1001290

Outcome Measures

Primary Outcome Measures

1. 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)]

2. Number of Participants Based on Severity of AEs [From start of study drug up to EOS (up to Day 42)]

3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Baseline up to EOS (Day 42)]

4. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [Baseline up to EOS (Day 42)]

5. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [Baseline up to EOS (Day 42)]

Secondary Outcome Measures

1. 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]

2. 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]

3. Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [31 days]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

For Cohort 1 only:

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

For Cohort 2 only:

1. 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:

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

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

3. 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

1. No nicotine use

2. 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

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ACT	Anaheim	California	United States	92801

Sponsors and Collaborators

• Gasherbrum Bio, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gasherbrum Bio, Inc
• ClinicalTrials.gov Identifier: NCT05893043
• Other Study ID Numbers: GSBR-1290-03
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 7, 2023