Non-alcoholic SteatohepatitisPhase 1NCT06716905

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

A Phase 1 study testing ACT500 tablets in people with Non-alcoholic Steatohepatitis, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Non-alcoholic Steatohepatitis
What is being tested?: ACT500 tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteChina
Study dates: 6 Mar 2025to 22 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

Who cannot join

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;

Show all 26Show fewer

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;
Participated in or currently participating in other new drug or medical device clinical trials within 30 days before the first dose (or 5 half-lives, whichever is longer), or currently undergoing follow-up of another clinical study;
Unable to swallow oral medication, having clinically significant gastrointestinal abnormalities (such as post-gastrointestinal resection, post-gastrointestinal anastomosis, chronic diarrhea, and intestinal obstruction, etc.) or existing conditions that, in the investigator's judgment, significantly affect gastrointestinal absorption;
Poor venous access, unable to tolerate venipuncture, or having a history of clinically significant syncope or needle phobia as judged by the investigator;
History of drug or substance abuse;
Positive results for any of the following tests during the screening period: human immunodeficiency virus antibody (HIV-Ab), syphilis antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab);
Heavy smoking (defined as more than 5 cigarettes per day) or use of nicotine-containing products (such as snuff, nicotine patches, nicotine gum, e-cigarettes, simulated cigarettes, or inhalers) within 6 months before screening; or unable to quit smoking (stop nicotine intake) during the trial period;
A history of alcohol abuse within 90 days before screening, or positive alcohol test results at D-1; or unable to abstain from alcohol intake during the trial period; alcohol abuse is defined as an average weekly intake of more than 14 standard drinks (1 standard drink contains 14g of alcohol, such as 45ml of spirits with an alcohol concentration of 40% or 180ml of wine with an alcohol concentration of 10%);
Pregnant or breastfeeding women;
The investigator believes that the participant has other conditions that may affect compliance or are unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongnan Hospital of Wuhan University
Wuhan, Hubei

Other trials in China

About this study

Official title: 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

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
Being tested: ACT500 tablets, Placebo
Keywords: Non-alcoholic Steatohepatitis, ACT500, NM6606, pharmacokinetic
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06716905
Study group	Role	What they receive
Part 1:ACT500 Tablets	Experimental	Not described Receives: Drug: ACT500 tablets
Part 1: Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Part 2:ACT500 Tablets	Experimental	Not described Receives: Drug: ACT500 tablets
Part 2: Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Event（AE）
Measured: SAD:Day1-8; MAD:Day1-22.
Serious Adverse Event
Measured: SAD:Day1-8; MAD:Day1-22.
body temperature
Measured: SAD:Day1-5; MAD:Day1,Day7-22.
respiration
Measured: SAD:Day1-5; MAD:Day1,Day7-22.
pulse
Measured: SAD:Day1-5; MAD:Day1,Day7-22.
heart rate
Measured: SAD:Day1-5; MAD:Day1,Day7-22.
blood pressure
Measured: 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).
Measured: SAD:Day1,Day3-8; MAD:Day1,Day3-22.
Number of Participants with 12-Lead Electrocardiogram Findings
Measured: SAD:Day-1,Day5 ; MAD:Day-1,Day3,Day8and D14.
Number of Participants with Dynamic electrocardiogram（ECG）Findings
Measured: SAD:Day1; MAD:Day1,Day7.
Number of Participants with Abnormal Laboratory Parameters Findings
Measured: SAD:Day1-8; MAD:Day1-22.

Secondary outcomes (22)

Maximum concentration (Cmax)
Measured: SAD:Day1-5;
Time to maximum concentration(Tmax)
Measured: 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)
Measured: SAD:Day1-5;
The area under the plasma concentration-time curve from the time of initial dosing to infinity (AUC0-∞)
Measured: SAD:Day1-5;
Apparent terminal elimination half-life (t1/2).
Measured: SAD:Day1-5;
Clearance (CL/F)
Measured: SAD:Day1-5;
Apparent Volume of Distribution (Vd/F)
Measured: SAD:Day1-5;
Elimination Rate Constant（Kel）
Measured: SAD:Day1-5;
Mean Residence Time（MRT）
Measured: SAD:Day1-5;
Steady-state trough concentration(Cmin,ss)
Measured: MAD:Day1-8;
Steady-state peak concentration(Cmax,ss)
Measured: MAD:Day1-8;
Average steady-state plasma concentration(Cav,ss)
Measured: MAD:Day1-8;
Elimination half-life(t1/2,ss)
Measured: MAD:Day1-8;
Clearance (CLss/F)
Measured: MAD:Day1-8;
Apparent Volume of Distribution (Vd/Fss)
Measured: MAD:Day1-8;
Accumulation Index (RAC)
Measured: MAD:Day1-8;
The area under the plasma concentration-time curve from the time of the last dose to the time of the last measurable concentration point (AUC0-t,ss)
Measured: MAD:Day1-8;
The area under the plasma concentration-time curve within one dosing interval after the last dose (AUC0-τ)
Measured: MAD:Day1-8;
The area under the plasma concentration-time curve extrapolated from the last dose to infinity (AUC0-∞,ss)
Measured: MAD:Day1-8;
Coefficient of Fluctuation (DF)
Measured: MAD:Day1-8;
Pharmacokinetic (PK):Plasma Concentrations of ACT500
Measured: SAD:Day1-4;MAD:Day1-8;
Changes of biomarkers after single and multiple oral dosing compared to baseline
Measured: SAD:Day1-5;MAD:Day1-8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 202522 Sep 2025

First posted4 Dec 2024
Study start6 Mar 2025
Primary completion22 Sep 2025
Study completion22 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06716905
Sponsor's protocol ID: ACT500-4/01
Status last verified: Feb 2026
First submitted: 13 Nov 2024
Last updated: 17 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06716905
Acronym / sponsor ID: ACT500-4/01
Conditions: Non-alcoholic Steatohepatitis
Keywords: Non-alcoholic Steatohepatitis, ACT500, NM6606, pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Zhongnan Hospital
Study start: 6 Mar 2025 (actual)
Primary completion: 22 Sep 2025 (actual)
Study completion: 22 Sep 2025 (actual)
First posted: 4 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (26 listed)

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];

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACT500 tabletsParticipants will receive a single ascending oral dose of ACT500 Tablets under fasting state on the first day in Part 1	Drug	Part 1:ACT500 Tablets
PlaceboParticipants will receive placebo matched to ACT500 Tablets.	Drug	Part 1: Placebo
ACT500 tabletsParticipants will receive multiple ascending oral dose of ACT500 Tablets under fasting state once daily for 7 days in Part 2.	Drug	Part 2:ACT500 Tablets
PlaceboParticipants will receive placebo matched to ACT500 Tablets.	Drug	Part 2: Placebo

Primary outcome

Adverse Event（AE）
Time frame: SAD:Day1-8; MAD:Day1-22.
Serious Adverse Event
Time frame: SAD:Day1-8; MAD:Day1-22.
body temperature
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
respiration
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
pulse
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
heart rate
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
blood pressure
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
Physical Examination
Time frame: SAD:Day1,Day3-8; MAD:Day1,Day3-22.
Physical examination includes general condition, head and neck, lymph nodes, skin, chest, abdomen, and musculoskeletal system (including limbs and spine).
Number of Participants with 12-Lead Electrocardiogram Findings
Time frame: SAD:Day-1,Day5 ; MAD:Day-1,Day3,Day8and D14.
Number of Participants with Dynamic electrocardiogram（ECG）Findings
Time frame: SAD:Day1; MAD:Day1,Day7.
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: SAD:Day1-8; MAD:Day1-22.

22 secondary outcomes

Maximum concentration (Cmax)
Time frame: SAD:Day1-5;
Time to maximum concentration(Tmax)
Time frame: 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)
Time frame: SAD:Day1-5;
The area under the plasma concentration-time curve from the time of initial dosing to infinity (AUC0-∞)
Time frame: SAD:Day1-5;
Apparent terminal elimination half-life (t1/2).
Time frame: SAD:Day1-5;
Clearance (CL/F)
Time frame: SAD:Day1-5;
Apparent Volume of Distribution (Vd/F)
Time frame: SAD:Day1-5;
Elimination Rate Constant（Kel）
Time frame: SAD:Day1-5;
Mean Residence Time（MRT）
Time frame: SAD:Day1-5;
Steady-state trough concentration(Cmin,ss)
Time frame: MAD:Day1-8;
Steady-state peak concentration(Cmax,ss)
Time frame: MAD:Day1-8;
Average steady-state plasma concentration(Cav,ss)
Time frame: MAD:Day1-8;
Elimination half-life(t1/2,ss)
Time frame: MAD:Day1-8;
Clearance (CLss/F)
Time frame: MAD:Day1-8;
Apparent Volume of Distribution (Vd/Fss)
Time frame: MAD:Day1-8;
Accumulation Index (RAC)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve from the time of the last dose to the time of the last measurable concentration point (AUC0-t,ss)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve within one dosing interval after the last dose (AUC0-τ)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve extrapolated from the last dose to infinity (AUC0-∞,ss)
Time frame: MAD:Day1-8;
Coefficient of Fluctuation (DF)
Time frame: MAD:Day1-8;
Pharmacokinetic (PK):Plasma Concentrations of ACT500
Time frame: SAD:Day1-4;MAD:Day1-8;
Changes of biomarkers after single and multiple oral dosing compared to baseline
Time frame: SAD:Day1-5;MAD:Day1-8.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Non-alcoholic Steatohepatitis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JianYing Huang principal investigator

Zhongnan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACT500 tablets in people with Non-alcoholic Steatohepatitis, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event（AE） (time frame: SAD:Day1-8; MAD:Day1-22.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.