NCT05118516

Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Gannex Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ASC43F	One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2021-11-12
• Last updated: 2024-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study