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

Xiamen Amoytop Biotech Co., Ltd.1 site in 1 country72 target enrollmentMarch 6, 2025

ConditionsNon-alcoholic Steatohepatitis

InterventionsACT500 tablets Placebo

DrugsACT500 tablets Placebo

Overview

Phase: Phase 1
Intervention: ACT500 tablets
Conditions: Non-alcoholic Steatohepatitis
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Enrollment: 72
Locations: 1
Primary Endpoint: Serious Adverse Event
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 6, 2025

End Date

September 22, 2025

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Part 1:ACT500 Tablets

Intervention: ACT500 tablets

Part 1: Placebo

Intervention: Placebo

Part 2:ACT500 Tablets

Intervention: ACT500 tablets

Part 2: Placebo

Intervention: Placebo

Outcomes