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

NCT06716905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhongnan Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JianYing Huang · Zhongnan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2025-09-22
Completion
2025-09-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716905 on ClinicalTrials.gov