drugset / Trial / NCT07462455
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)
Phase 1
Not yet recruiting
24 enrolled
Xiamen Amoytop Biotech Co., Ltd.
Beijing Tsinghua Changgeng Hospital · collab
Non-randomizedSequentialOpen-labelOther
Summary
This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.
Timeline
- Start
- 2026-03-31
- Primary completion
- 2027-02-28
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ACT500 | Unknown | 60 mg | Oral |
| Subject | ACT500 | Unknown | 160 mg | Oral |
| Subject | ACT500 | Unknown | 300 mg | Oral |
| Subject | ACT500 | Unknown | 400 mg | Oral |