NCT04679129

Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Gannex Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a first in human study of single and multiple ascending doses and food effect of ASC42. This study consists of 8 cohorts and is divided as follows: Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASC42	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-05-03
• Completion: 2021-06-03
• First posted: 2020-12-22
• Last updated: 2024-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study