A Phase 1 interventional study of HEC169584 capsule and placebo in Non - Alcoholic Steatohepatitis, sponsored by Sunshine Lake Pharma Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
This trial adopts a single - center, randomized, double - blind, placebo - controlled, dose - escalation trial design.
This trial is divided into two parts. The first part consists of a single - ascending - dose (SAD) trial and a food - effect (FE) trial. The second part is a multiple - ascending - dose (MAD) tria.
Screening will be conducted within 28 days prior to the first drug administration. After all test results are obtained, inclusion and exclusion criteria will be verified. Eligible subjects will be admitted to the research center one day before drug administration (D - 1). Researchers will assign random numbers to eligible subjects of the same dose group in ascending order according to their screening numbers, and conduct relevant examinations and collect blood, urine, and fecal samples (if necessary) at the time points specified in the protocol.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 83 studies on the registry; 13 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On day1 subjects will take the experiment drug on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule
Single ascending-dose study: on day1 subjects will take the 30 mg experiment drug on an empty stomach with 240ml warm water ;
Drug: HEC169584 capsule · Drug: placebo
Single ascending-dose study: on day1, subjects will take 70 mg the experiment drug or placeble on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule · Drug: placebo
Single ascending-dose study: on day1, subjects will take 150 mg the experiment drug or placeble on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule · Drug: placebo
Single ascending-dose study: on day1, subjects will take 300 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Subjects also need to take experiment drug after high - fat and high - calorie meals on day 15
Drug: HEC169584 capsule · Drug: placebo
Single ascending-dose study: on day1, subjects will take 450 mg the experiment drug or placeble on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule · Drug: placebo
Single ascending-dose study: on day1, subjects will take 600 mg the experiment drug or placeble on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule · Drug: placebo
Arm Description: Single ascending-dose study: on day1, subjects will take 800 mg the experiment drug or placeble on an empty stomach with 240ml warm water.
Drug: HEC169584 capsule · Drug: placebo
Multiple ascending-dose study: Day1-Day14 , subjects will take 70 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach.
Drug: HEC169584 capsule · Drug: placebo
Multiple ascending-dose study: Day1-Day14 , subjects will take 150 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach.
Drug: HEC169584 capsule · Drug: placebo
Multiple ascending-dose study: Day1-Day14 , subjects will take 300 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach.
Drug: HEC169584 capsule · Drug: placebo
Each dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
The placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Adverse event
Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.
Time frame: up to 27 days
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: up to 48 hours
PK parameters - AUC0-t
Area under the concentration versus time curve (AUC) from time zero to 48 h (AUC0-48 )
Time frame: up to 48 hours
PK parameters - Cmax
Maximum Plasma Concentration ( Cmax)
Time frame: up to 48 hours
PK parameters - tmax
Time to peak(tmax)
Time frame: up to 48 hours
PK parameters - t½
Apparent terminal elimination half-life(t½)
Time frame: up to 48 hours
PK parameters -Vz/F
Apparent volume of distribution(Vz/F)
Time frame: up to 48 hours
PK parameters -MRT
The Mean Residence Time#(MRT)
Time frame: up to 48 hours
PK parameters -CL/F
The Apparent Clearance (CL/F)
Time frame: up to 48 hours
PK parameters -The Accumulation Ratio(R)
The Accumulation Ratio(R)
Time frame: up to 15 days
PK parameters -Food Effect on the Cmax
The geometric mean percentage of Cmax between post - meal administration and fasting administration
Time frame: up to 48 hours
PK parameters -Food Effect on the AUC
The geometric mean percentage of AUC between post - meal administration and fasting administration
Time frame: up to 48 hours
The pharmacodynamics of HEC169584 capsules
The pharmacodynamics of HEC169584 capsules was preliminarily explored through SHBG(Sex Hormone - Binding Globulin) and Fasting blood lipid.
Time frame: Time Frame: up to 28 days
C-QT study, drug metabolism and excretion, drug - drug interaction characteristics (if necessary), pharmacogenomic characteristics (if necessary)
Explore the impact of the blood concentration of HEC169584 capsules on the QTc interval. Explore characteristics such as drug metabolism and excretion, drug - drug interactions (if necessary), and pharmacogenomic characteristic (if necessary).
Time frame: up to 28 days
Plan to share: No
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