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

NCT06427590 | Completed Phase 1

• 1 other identifier: ASC47-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Weight Management

Keywords

ASC47

Outcome Measures

Primary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.

  up to 57 days

• ECG QT Interval

  Evaluate the ECG QT Interval after single doses of ASC47.

  up to 57 days

• Blood cell

  Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.

  up to 57 days

• Hematology

  Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.

  up to 57 days

Secondary Outcomes (7)

• AUC of ASC47

  up to 57 days

• Cmax of ASC47

  up to 57 days

• Cmin of ASC47

  up to 57 days

• T1/2 of ASC47

  up to 57 days

• CL/F of ASC47

  up to 57 days

Study Arms (4)

SAD in healthy subjects-Cohort 1

EXPERIMENTAL

SAD cohort 1, dose 1

Drug: ASC47; Drug: Matching placebo

SAD in healthy subjects-Cohort 2

EXPERIMENTAL

SAD Cohort 2, dose 2

Drug: ASC47; Drug: Matching placebo

SAD in healthy subjects-Cohort 3

EXPERIMENTAL

SAD Cohort 3, dose 3

Drug: ASC47; Drug: Matching placebo

SAD in patients with obesity-Cohort 3A

EXPERIMENTAL

SAD Cohort 3A, dose 3

Drug: ASC47; Drug: Matching placebo

Interventions

ASC47 DRUG

single subcutaneous injection of ASC47

SAD in healthy subjects-Cohort 1; SAD in healthy subjects-Cohort 2; SAD in healthy subjects-Cohort 3; SAD in patients with obesity-Cohort 3A

Matching placebo DRUG

single subcutaneous injection of Placebo

SAD in healthy subjects-Cohort 1; SAD in healthy subjects-Cohort 2; SAD in healthy subjects-Cohort 3; SAD in patients with obesity-Cohort 3A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (1)

Ascletis

Herston, Queensland, 4006, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 24, 2024
• Study Start: July 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)