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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
Sponsor: Ascletis Pharma (China) Co., Limited
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-08-27
Completion Date
2027-06
Last Updated
2026-09-25
Healthy Volunteers
Yes
Conditions
Interventions
ASC35 Injection B, for subcutaneous use
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.
ASC35 Placebo Injection B, for subcutaneous use
ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
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
Locations (1)
Ascletis Clinical Site
Baltimore, Maryland, United States