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Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06716905•Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants are willing and able to sign a written informed consent form voluntarily before starting any study-related procedures and are willing to comply with all required study procedures;
•Males or females between 18 and 55 years of age (inclusive) at the time of screening;
•Body Mass Index (BMI) between 19-26 kg/m\^2 (inclusive) at the time of screening, with a weight of at least 50 kg;
•Blood pressure within the normal range at the time of screening: systolic pressure: 90-139 mmHg, diastolic pressure: 60-89 mmHg (inclusive of the critical values);
•Participants of men and women of childbearing potential willing to use highly effective contraceptive measures (condoms, contraceptive sponges, contraceptive gels, contraceptive films, intrauterine devices, oral or injectable contraceptives, subdermal implants, etc.) from the time of signatures of the informed consent form until 90 days after the last administration of the study medication; and women of childbearing potential must have a negative serum pregnancy tests at the time of screening and at the time of the D-1 examination;

Exclusion Criteria

•Allergic to the study drug or any of its components;
•Have previously used the study drug;
•Have clinically significant diseases, including but not limited to abnormality in liver or kidney, blood, digestive (including bleeding, infection, obstruction, or diarrhea greater than grade 1), respiratory, cardiovascular and cerebrovascular, endocrine, metabolic disorders, nervous system diseases, etc., which assessed by the investigator unsuitable for inclusion;
•Clinical significant abnormality in vital signs, physical examination, laboratory tests, or ECG at screening, as assessed by the investigator unsuitable for inclusion;
•QTcF \> 450ms (males), QTcF \> 480ms (females) at screening \[Fridericia's formula: QTcF = QT/(RR)\^1/3\];
•Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m\^2 at screening;
•A history of unstable cardiovascular and cerebrovascular diseases within 6 months prior to screening, including acute myocardial infarction, stroke, arrhythmia, etc.;
•Existing liver disease or unexplained elevation of liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin or direct bilirubin \> 1.5×ULN at screening or D-1, or D-1 test value is more than 50% higher than the screening test value);
•Respiratory infections (upper and/or lower respiratory tract) treated with antibiotics within 12 weeks before screening;
•Infectious diseases within the screening period (within 28 days before the first dose) that, in the investigator's judgment, would affect the participant's ability to participate in the trial;
+16 more criteria

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

March 6, 2025

Primary Completion Date

September 22, 2025

Completion Date

September 22, 2025

Last Updated

February 17, 2026

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Steatohepatitis

Interventions

ACT500 tablets

DRUG

Placebo

DRUG

ACT500 tablets

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

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