Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults
Gasherbrum Bio, Inc is starting a phase 1b study of GSBR-1290 in adult overweight or obese healthy subjects.
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.
The clinical trial started in January 9, 2023 and will continue throughout September 21, 2023.
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV.
Inclusion Criteria:
- Provided evidence of a signed consent.
- Age ≥ 18 and ≤ 75 years.
- Healthy overweight/obese adult men and women with body mass index ≥ 27. and ≤ 40 kg/m2.
- No nicotine use.
- Have a suitable venous access for blood sampling.
Exclusion Criteria:
- 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
- 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.
- Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
- 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
- Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
- Known hypersensitivity to any of the study drug ingredients
- Any other condition or prior therapy that would make the participant unsuitable for this study
The locations are the Anaheim Clinical Trials, Anaheim, California, United States; ProSciento, Inc, Chula Vista, California, United States; QPS Miami Research Associates, Miami, Florida, United States; Progressive Medical Research, Port Orange, Florida, United States. For contact details visit: https://ichgcp.net/clinical-trials-registry/NCT05762471
