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
Overview
- Phase
- Phase 1
- Intervention
- ASC30 Injection, for subcutaneous use or placebo
- Conditions
- Not specified
- Sponsor
- Ascletis Pharma (China) Co., Limited
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Incidence of AEs, SAEs (Safety and tolerability) of ASC30
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Have evidence of any clinically significant active or chronic disease.
- •Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
- •Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- •Have a history of acute or chronic pancreatitis.
- •Participants with a known clinically significant gastric emptying abnormality.
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- •Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Arms & Interventions
SAD Cohort 1
SAD Dose 1
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 2
SAD Dose 2
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 3
SAD Dose 3
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 4
SAD Dose 4
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 5
SAD Dose 5
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 6
SAD Dose 6
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 7
SAD Dose 7
Intervention: ASC30 Injection, for subcutaneous use or placebo
SAD Cohort 8
SAD Dose 8
Intervention: ASC30 Injection, for subcutaneous use or placebo
MAD Cohort 1
MAD Dose 1
Intervention: ASC30 Injection, for subcutaneous use or placebo
MAD Cohort 2
MAD Dose 2
Intervention: ASC30 Injection, for subcutaneous use or placebo
MAD Cohort 3
MAD Dose 3
Intervention: ASC30 Injection, for subcutaneous use or placebo
Outcomes
Primary Outcomes
Incidence of AEs, SAEs (Safety and tolerability) of ASC30
Time Frame: Up to Day169
A summary of AEs, SAEs and other non-serious adverse events
Secondary Outcomes
- Cmax of ASC30(Up to Day169)
- Change From Baseline in Body Weight(Up to Day169)