A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Weight Management
- Sponsor
- Ascletis Pharma (China) Co., Limited
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.
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
MAD Cohort 2
MAD dose 2
Intervention: Placebo
MAD Cohort 3
MAD dose 3
Intervention: ASC30
MAD Cohort 3
MAD dose 3
Intervention: Placebo
SAD Cohort 1
SAD dose 1
Intervention: ASC30
SAD Cohort 1
SAD dose 1
Intervention: Placebo
SAD Cohort 2
SAD dose 2
Intervention: ASC30
SAD Cohort 2
SAD dose 2
Intervention: Placebo
SAD Cohort 3
SAD dose 3
Intervention: ASC30
SAD Cohort 3
SAD dose 3
Intervention: Placebo
SAD Cohort 4
SAD dose 4
Intervention: ASC30
SAD Cohort 4
SAD dose 4
Intervention: Placebo
SAD Cohort 5
SAD dose 5
Intervention: ASC30
SAD Cohort 5
SAD dose 5
Intervention: Placebo
MAD Cohort 1
MAD dose 1
Intervention: ASC30
MAD Cohort 1
MAD dose 1
Intervention: Placebo
MAD Cohort 2
MAD dose 2
Intervention: ASC30
Outcomes
Primary Outcomes
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
Time Frame: Up to Day 8
A summary of AEs, SAEs and other non-serious adverse events
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
Time Frame: Up to Day 28
A summary of AEs, SAEs and other non-serious adverse events
Secondary Outcomes
- Cmax of ASC30 (SAD)(Up to Day 8)
- Cmax of ASC30 (MAD)(Up to Day 28)
- Change From Baseline in Body Weight (MAD)(Up to Day 28)