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

Phase 1 Completed 64 enrolled Gannex Pharma Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2020-11-30
Primary completion: 2021-05-03
Completion: 2021-06-03

Publications

He H, Wu JJ. Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist. Drugs R D. 2023 Dec;23(4):453-464. doi: 10.1007/s40268-023-00444-4. Epub 2023 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASC42	Unknown	5 mg	Oral
Subject	ASC42	Unknown	15 mg	Oral
Subject	ASC42	Unknown	50 mg	Oral
Subject	ASC42	Unknown	200 mg	Oral

Indications

No indication recorded.