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

Phase 1

Completed

• Conditions: Chronic Weight Management
• Interventions: Drug: ASC47; Drug: Matching placebo

• Registration Number: NCT06427590
• Lead Sponsor: Gannex Pharma Co., Ltd.

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-19
• Study First Posted: 2024-05-24
• Study Start: 2024-07-13
• Status Verified: 2024-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD in healthy subjects-Cohort 1	ASC47	SAD cohort 1, dose 1
SAD in healthy subjects-Cohort 1	Matching placebo	SAD cohort 1, dose 1
SAD in healthy subjects-Cohort 2	ASC47	SAD Cohort 2, dose 2
SAD in healthy subjects-Cohort 2	Matching placebo	SAD Cohort 2, dose 2
SAD in healthy subjects-Cohort 3	ASC47	SAD Cohort 3, dose 3
SAD in healthy subjects-Cohort 3	Matching placebo	SAD Cohort 3, dose 3
SAD in patients with obesity-Cohort 3A	ASC47	SAD Cohort 3A, dose 3
SAD in patients with obesity-Cohort 3A	Matching placebo	SAD Cohort 3A, dose 3

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ascletis; 🇦🇺 Herston, Queensland, Australia