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

NCT06716905 | Completed Phase 1

• 1 other identifier: ACT500-4/01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Steatohepatitis

Keywords

Non-alcoholic Steatohepatitis; ACT500; NM6606; pharmacokinetic

Outcome Measures

Primary Outcomes (11)

• Adverse Event（AE）

  SAD:Day1-8; MAD:Day1-22.

• Serious Adverse Event

  SAD:Day1-8; MAD:Day1-22.

• body temperature

  SAD:Day1-5; MAD:Day1,Day7-22.

• respiration

  SAD:Day1-5; MAD:Day1,Day7-22.

• pulse

  SAD:Day1-5; MAD:Day1,Day7-22.

• heart rate

  SAD:Day1-5; MAD:Day1,Day7-22.

• blood pressure

  SAD:Day1-5; MAD:Day1,Day7-22.

• Physical Examination

  Physical examination includes general condition, head and neck, lymph nodes, skin, chest, abdomen, and musculoskeletal system (including limbs and spine).

  SAD:Day1,Day3-8; MAD:Day1,Day3-22.

• Number of Participants with 12-Lead Electrocardiogram Findings

  SAD:Day-1,Day5 ; MAD:Day-1,Day3,Day8and D14.

• Number of Participants with Dynamic electrocardiogram（ECG）Findings

  SAD:Day1; MAD:Day1,Day7.

• Number of Participants with Abnormal Laboratory Parameters Findings

  SAD:Day1-8; MAD:Day1-22.

Secondary Outcomes (22)

• Maximum concentration (Cmax)

  SAD:Day1-5;

• Time to maximum concentration(Tmax)

  SAD:Day1-5;MAD:Day1-8

• The area under the plasma concentration-time curve from the time of initial dosing to the time of the last measurable concentration point (AUC0-t)

  SAD:Day1-5;

• The area under the plasma concentration-time curve from the time of initial dosing to infinity (AUC0-∞)

  SAD:Day1-5;

• Apparent terminal elimination half-life (t1/2).

  SAD:Day1-5;

Study Arms (4)

Part 1:ACT500 Tablets

EXPERIMENTAL

Drug: ACT500 tablets

Part 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part 2:ACT500 Tablets

EXPERIMENTAL

Drug: ACT500 tablets

Part 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACT500 tablets DRUG

Participants will receive a single ascending oral dose of ACT500 Tablets under fasting state on the first day in Part 1

Part 1:ACT500 Tablets

Placebo DRUG

Participants will receive placebo matched to ACT500 Tablets.

Part 1: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• Allergic to the study drug or any of its components;
• Have previously used the study drug;
• 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;
• History of tuberculosis;
• History of malignant tumors (except for basal cell carcinoma or squamous cell carcinoma of the skin);
• Serious trauma or surgery within 28 days before the first dose, or planning major surgery during the study period;
• Blood donation or significant blood loss (≥400mL) within 56 days before the first dose, or having received a blood transfusion;
• Use of any medication (including prescription drugs, over-the-counter drugs, traditional Chinese medicine, etc.) or health products within 14 days before the first dose (or 5 half-lives, whichever is longer);
• Use of strong inhibitors or inducers of CYP450 enzymes and/or P-gp within 28 days before the first dose, or needing to continue using the above drugs during the study period;
• Received live or attenuated vaccines within 30 days before the first dose, or planning to receive them during the study period;

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead
• Zhongnan Hospital: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• JianYing Huang

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 4, 2024
• Study Start: March 6, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)