A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight

Summary

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  ASC35 Injection B, for subcutaneous use

  ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.

• Drug
  ASC35 Placebo Injection B, for subcutaneous use

  ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B

• Drug
  Tirzepatide

  Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection

Location