NCT04527250

A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.

Detailed description

The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASC41	ASC41,1mg/table;5mg/table
DRUG	ASC41 placebo	ASC41 placebo,1mg/table;5mg/table

Timeline

• Start date: 2020-09-16
• Primary completion: 2020-12-18
• Completion: 2020-12-30
• First posted: 2020-08-26
• Last updated: 2021-08-20

Locations

1 site across 1 country: China