A Phase I, Randomized, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Are Overweight

Ascletis Pharma (China) Co., Limited

Summary

This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Have provided informed consent before initiation of any study-specific procedures. 2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive) at screening. 3. Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to \<30 kg/m2). 4. Female participant is eligible to participate if she is not pregnant, breastfeeding, or planning to breastfeed, and one of the following conditions applies: * Is a woman of nonchildbearing potential (postmenopausal \[12 months of amenorrhea with follicle-stimulating hormone le…

Interventions

Drug
ASC36 tablets, for oral use
ASC36 tablets are an investigational formulation of ASC36 administered orally
Drug
ASC36 placebo tablets
ASC36 placebo tablets are a plaecbo formulation matching ASC36 tablets, administered orally

Location

Ascletis Clinical Site
South Miami, Florida

A Phase I, Randomized, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Are Overweight

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions