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

NASH Clinical Trial

Official title:
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 Subjects

Clinical Trial 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, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.

Clinical Trial Description

The study will consist of five cohorts, each with different doses of ASC47. Cohorts 1 and 2 have 6 subjects, of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. Cohorts 3, 4 and 5 have 8 subjects, of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06427590
Study type Interventional
Source Gannex Pharma Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date June 2024
Completion date April 2025
View Details
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