Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults

illustrative imageGasherbrum 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:

  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

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

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