Randomized, Double-blind, Placebo-controlled Phase 1b Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects

• Status: Recruiting
• Trial end date: 2023-09-21
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV).

This study includes 3 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 28

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gasherbrum Bio, Inc

Criteria

Inclusion Criteria:

1. Provided evidence of a signed consent

2. Age ≥ 18 and ≤ 75 years

3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2

4. No nicotine use

5. Have a 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 major 3 months

2. A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.

3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval

4. Liver function test results elevated > 2.0-fold above the ULN for gamma gutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN

5. Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area

6. Known hypersensitivity to any of the study drug ingredients

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