A Phase I/IIa, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection, for Subcutaneous Use in Participants With Obesity
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 efficacy of ASC30 injection
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Have provided informed consent before initiation of any study-specific procedures.
• Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
• No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Locations
United States
Texas
Ascletis clinical site
RECRUITING
San Antonio
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2026-04
Participants
Target number of participants: 115
Treatments
Experimental: SAD Cohort 1
SAD Dose 1
Experimental: SAD Cohort 2
SAD Dose 2
Experimental: SAD Cohort 3
SAD Dose 3
Experimental: SAD Cohort 4
SAD Dose 4
Experimental: SAD Cohort 5
SAD Dose 5
Experimental: SAD Cohort 6
SAD Dose 6
Experimental: SAD Cohort 7
SAD Dose 7
Experimental: SAD Cohort 8
SAD Dose 8
Experimental: MAD Cohort 1
MAD Dose 1
Experimental: MAD Cohort 2
MAD Dose 2
Experimental: MAD Cohort 3
MAD Dose 3
Related Therapeutic Areas
Sponsors
Leads: Ascletis Pharma (China) Co., Limited