Weight Management
Conditions
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.
Interventions
DRUGASC30
Tablet, QD
OTHERPlacebo
Tablets, QD
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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). 3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion criteria
1. Have evidence of any clinically significant active or chronic disease. 2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus. 3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. 4. Have a history of acute or chronic pancreatitis. 5. Participants with a known clinically significant gastric emptying abnormality. 6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD) | 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) | Up to Day 28 | A summary of AEs, SAEs and other non-serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of ASC30 (SAD) | Up to Day 8 | PK parameters of ASC30 |
| Cmax of ASC30 (MAD) | Up to Day 28 | PK parameters of ASC30 |
| Change From Baseline in Body Weight (MAD) | Up to Day 28 | Change From Baseline in Body Weight |
Countries
United States
Outcome results
None listed