A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity

Ascletis Pharma (China) Co., Limited

Status and phase: Completed; Phase 1

Conditions: Weight Management

Treatments: Drug: ASC30; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06680440

ASC30-102

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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72 participants in 8 patient groups

SAD Cohort 1

Experimental group

Description:

SAD dose 1

Treatment:

Other: Placebo

Drug: ASC30

SAD Cohort 2

Experimental group

Description:

SAD dose 2

Treatment:

Other: Placebo

Drug: ASC30

SAD Cohort 3

Experimental group

Description:

SAD dose 3

Treatment:

Other: Placebo

Drug: ASC30

SAD Cohort 4

Experimental group

Description:

SAD dose 4

Treatment:

Other: Placebo

Drug: ASC30

SAD Cohort 5

Experimental group

Description:

SAD dose 5

Treatment:

Other: Placebo

Drug: ASC30

MAD Cohort 1

Experimental group

Description:

MAD dose 1

Treatment:

Other: Placebo

Drug: ASC30

MAD Cohort 2

Experimental group

Description:

MAD dose 2

Treatment:

Other: Placebo

Drug: ASC30

MAD Cohort 3

Experimental group

Description:

MAD dose 3

Treatment:

Other: Placebo

Drug: ASC30