A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects

Ascletis Pharma (China) Co., Limited

Status and phase: Completed; Phase 1

Conditions: Chronic Weight Management

Treatments: Drug: ASC47; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06427590

ASC47-101

Details and patient eligibility

About

This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.

This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion Criteria:

• Subject have provided informed consent before initiation of any study-specific procedures
• Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
• Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Key exclusion Criteria:

• Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
• Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
• Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
• Have a history of febrile illness within 14 days prior to screening.
• Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
• Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
• Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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28 participants in 4 patient groups

SAD in healthy subjects-Cohort 1

Experimental group

Description:

SAD cohort 1, dose 1

Treatment:

Drug: Matching placebo

Drug: ASC47

SAD in healthy subjects-Cohort 2

Experimental group

Description:

SAD Cohort 2, dose 2

Treatment:

Drug: Matching placebo

Drug: ASC47

SAD in healthy subjects-Cohort 3

Experimental group

Description:

SAD Cohort 3, dose 3

Treatment:

Drug: Matching placebo

Drug: ASC47

SAD in patients with obesity-Cohort 3A

Experimental group

Description:

SAD Cohort 3A, dose 3

Treatment:

Drug: Matching placebo

Drug: ASC47