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

May 7, 2025 updated by: Ascletis Pharma (China) Co., Limited

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will consist of 8 cohorts, each with different doses of ASC47.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Ascletis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAD in healthy subjects-Cohort 1
SAD cohort 1, dose 1
Drug: ASC47
single subcutaneous injection of ASC47
Drug: Matching placebo
single subcutaneous injection of Placebo
Experimental: SAD in healthy subjects-Cohort 2
SAD Cohort 2, dose 2
Drug: ASC47
single subcutaneous injection of ASC47
Drug: Matching placebo
single subcutaneous injection of Placebo
Experimental: SAD in healthy subjects-Cohort 3
SAD Cohort 3, dose 3
Drug: ASC47
single subcutaneous injection of ASC47
Drug: Matching placebo
single subcutaneous injection of Placebo
Experimental: SAD in patients with obesity-Cohort 3A
SAD Cohort 3A, dose 3
Drug: ASC47
single subcutaneous injection of ASC47
Drug: Matching placebo
single subcutaneous injection of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: up to 57 days
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
Time Frame: up to 57 days
Evaluate the ECG QT Interval after single doses of ASC47.
up to 57 days
Hematology
Time Frame: up to 57 days
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
up to 57 days
Blood cell
Time Frame: up to 57 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of ASC47
Time Frame: up to 57 days
Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.
up to 57 days
Cmax of ASC47
Time Frame: up to 57 days
Evaluate the Peak Plasma Concentration after single doses of ASC47.
up to 57 days
Cmin of ASC47
Time Frame: up to 57 days
Evaluate the Minimum Plasma Concentration after single doses of ASC47.
up to 57 days
T1/2 of ASC47
Time Frame: up to 57 days
Evaluate the Terminal-Phase Half-Life after single doses of ASC47
up to 57 days
CL/F of ASC47
Time Frame: up to 57 days
Evaluate the Apparent Systemic Clearance after single doses of ASC47.
up to 57 days
Vd/F of ASC47
Time Frame: up to 57 days
Evaluate the Apparent Volume of Distribution after single doses of ASC47.
up to 57 days
Lipid parameters
Time Frame: up to 57 days
Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.
up to 57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharma (China) Co., Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 19, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASC47-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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