NCT06716905

Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Dose Escalations of ACT500 (Formerly Known as NM6606) in Chinese Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a multiple-dose escalation study (Part2,MAD study phase). It's aimed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACT500 in healthy adult participants, and to explore possible metabolites and biomarkers of ACT500.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	ACT500 tablets	Participants will receive a single ascending oral dose of ACT500 Tablets under fasting state on the first day in Part 1
DRUG	Placebo	Participants will receive placebo matched to ACT500 Tablets.
DRUG	ACT500 tablets	Participants will receive multiple ascending oral dose of ACT500 Tablets under fasting state once daily for 7 days in Part 2.
DRUG	Placebo	Participants will receive placebo matched to ACT500 Tablets.

Timeline

• Start date: 2025-03-06
• Primary completion: 2025-09-22
• Completion: 2025-09-22
• First posted: 2024-12-04
• Last updated: 2026-02-17

Locations

1 site across 1 country: China