Non - Alcoholic SteatohepatitisPhase 1NCT07099118
A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects
A Phase 1 study testing HEC169584 capsule in people with Non - Alcoholic Steatohepatitis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects . Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Non - Alcoholic Steatohepatitis
- What is being tested?
- HEC169584 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 6 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects should understand and abide by the research procedures, volunteer to participate, and sign the informed consent form.
- When signing the informed consent form, subjects should be between 18 and 45 years old (including the boundary values), and both genders are eligible.
- Male subjects should weigh ≥ 50.0 kg, and female subjects should weigh ≥ 45.0 kg. For the single - dose trial, the body mass index [BMI = weight (kg) / height² (m²)] should be within the range of 18.0 - 28.0 kg/m² (including the boundary values). For the multiple - dose trial, the BMI should be within the range of 18.0 - 30.0 kg/m² (including the boundary values).
- Subjects enrolled in the MAD (Multiple - Ascending - Dose) trial should also meet the requirement that 2.6 mmol/L (100 mg/dL) ≤ LDL - C < 4.1 mmol/L (160 mg/dL).
- The results of vital signs, physical examinations, clinical laboratory tests, electrocardiograms, chest X - rays (posteroanterior view), abdominal color Doppler ultrasounds, etc. should be normal, or if judged as abnormal by the investigator, they should be of no clinical significance.
- Subjects (including their partners) should voluntarily adopt effective contraceptive measures from the screening stage until 3 months after the last drug administration, and should have no plans for sperm or egg donation.
Who cannot join
- Subjects had clinically significant diseases as follows (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, mental, or cardiovascular and cerebrovascular diseases) before screening.
- Subjects with allergic constitution (allergic to multiple drugs or foods).
- Subjects who smoked more than 5 cigarettes per day on average within 3 months before screening, or smoked within 48 hours before taking the investigational product, or could not stop using any tobacco products during the trial.
- Subjects had a history of dysphagia before screening, or had a history of gastrointestinal, hepatic, or renal diseases or surgeries that potentially affect the absorption, distribution, metabolism, and excretion of the investigational product (except uncomplicated appendectomy and hernia repair).
- Subjects had a history of alcoholism within 1 year before screening (consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or had a positive alcohol breath test during the screening period.
- Subjects had a history of drug abuse or used drugs within 2 years before screening, or had a positive urine drug screening during the screening period.
Show all 21Show fewer
- Subjects donated blood or lost blood ≥ 400 mL within 3 months before screening, or planned to donate blood within 1 month after the end of the trial.
- Subjects had a history of thyroid diseases, or the thyroid - stimulating hormone (TSH) index in the thyroid function test during the screening period was beyond the normal range.
- Subjects had a corrected QT interval (QTcF = QT/RR0.33 calculated by the Fridericia formula) of the 12 - lead electrocardiogram > 450 ms during screening.
- Subjects had a glomerular filtration rate < 90 mL/min (the glomerular filtration rate is calculated using the simplified MDRD formula: for men, eGFR = 186 × creatinine (mg/dL)-1.154 × age - 0.203; for women, eGFR = 186 × creatinine (mg/dL)-1.154 × age - 0.203 × 0.742). Note: The unit of creatinine in the formula is mg/dL. When calculating, the creatinine result in μmol/L needs to be converted to mg/dL, and 1 μmol/L = 0.01131 mg/dL.
- Subjects received vaccination within 1 month before screening, or planned to receive vaccination during the trial.
- Subjects took inhibitors and/or inducers of CYP3A4, CYP2C8, P - gp, or BCRP within 4 weeks before screening.
- Subjects took any prescription drugs, over - the - counter drugs, any vitamin products, or Chinese herbal medicines within 14 days before screening.
- Subjects consumed foods or beverages containing chocolate, caffeine, xanthine, alcohol, or grapefruit within 48 hours before the first drug administration.
- Subjects developed an acute illness or had concomitant medications from the screening stage to before the first drug administration.
- Subjects had a history of fainting at the sight of needles or blood, could not tolerate intravenous puncture for blood collection, or had difficulty in blood collection.
- Lactating or pregnant women, or women of child - bearing potential with a positive pregnancy test.
- Subjects participated in other clinical trials within 3 months before screening (if the subject withdrew from the study before treatment, that is, was not randomized or did not receive treatment, they can be enrolled in this study).
- Subjects tested positive for any one of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.
- Subjects had special dietary requirements and could not accept the unified diet.
- Subjects with other factors that, in the investigator's opinion, make them inappropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 49, Huayuan North Road, Haidian District, Beijing Municipality
Beijing, Beijing Municipality
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Doses of HEC169584 Capsules and the Effect of Food on Its Pharmacokinetics in Healthy Subjects
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
Read the detailed description
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.
- Conditions
- Non - Alcoholic Steatohepatitis
- Being tested
- HEC169584 capsule, placebo
- 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.
HEC169584 capsuleDrug
Each dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
placeboDrug
The placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
| Study group | Role | What they receive |
|---|---|---|
| Dose group-1 | Experimental | On day1 subjects will take the experiment drug on an empty stomach with 240ml warm water. Receives: Drug: HEC169584 capsule |
| Dose group-2 | Sham comparator | Single ascending-dose study: on day1 subjects will take the 30 mg experiment drug on an empty stomach with 240ml warm water ; Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-3 | Sham comparator | Single ascending-dose study: on day1, subjects will take 70 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-4 | Sham comparator | Single ascending-dose study: on day1, subjects will take 150 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-5 | Sham comparator | 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 Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-6 | Sham comparator | Single ascending-dose study: on day1, subjects will take 450 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-7 | Sham comparator | Single ascending-dose study: on day1, subjects will take 600 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-8 | Sham comparator | 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. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-9 | Sham comparator | Multiple ascending-dose study: Day1-Day14 , subjects will take 70 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-10 | Sham comparator | Multiple ascending-dose study: Day1-Day14 , subjects will take 150 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. Receives: Drug: HEC169584 capsule; Drug: placebo |
| Dose group-11 | Sham comparator | Multiple ascending-dose study: Day1-Day14 , subjects will take 300 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. Receives: Drug: HEC169584 capsule; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.
Measured: up to 27 days
Secondary outcomes (12)
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Measured: up to 48 hours
PK parameters - AUC0-t
Area under the concentration versus time curve (AUC) from time zero to 48 h (AUC0-48 )
Measured: up to 48 hours
PK parameters - Cmax
Maximum Plasma Concentration ( Cmax)
Measured: up to 48 hours
PK parameters - tmax
Time to peak(tmax)
Measured: up to 48 hours
PK parameters - t½
Apparent terminal elimination half-life(t½)
Measured: up to 48 hours
PK parameters -Vz/F
Apparent volume of distribution(Vz/F)
Measured: up to 48 hours
PK parameters -MRT
The Mean Residence Time#(MRT)
Measured: up to 48 hours
PK parameters -CL/F
The Apparent Clearance (CL/F)
Measured: up to 48 hours
PK parameters -The Accumulation Ratio(R)
The Accumulation Ratio(R)
Measured: up to 15 days
PK parameters -Food Effect on the Cmax
The geometric mean percentage of Cmax between post - meal administration and fasting administration
Measured: up to 48 hours
PK parameters -Food Effect on the AUC
The geometric mean percentage of AUC between post - meal administration and fasting administration
Measured: 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.
Measured: Time Frame: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start3 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion6 Mar 2027 (estimated)
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 Sunshine Lake Pharma 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DongYang Liu, doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099118
- Sponsor's protocol ID
- HEC169584-NASH-101
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Doses of HEC169584 Capsules and the Effect of Food on Its Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07099118
- Acronym / sponsor ID
- HEC169584-NASH-101
- Conditions
- Non - Alcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 6 Mar 2027 (estimated)
- First posted
- 1 Aug 2025 (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.
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose group-1 | Experimental | Drug: HEC169584 capsuleOn day1 subjects will take the experiment drug on an empty stomach with 240ml warm water. |
| Dose group-2 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle ascending-dose study: on day1 subjects will take the 30 mg experiment drug on an empty stomach with 240ml warm water ; |
| Dose group-3 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle ascending-dose study: on day1, subjects will take 70 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-4 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle ascending-dose study: on day1, subjects will take 150 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-5 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle 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 |
| Dose group-6 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle ascending-dose study: on day1, subjects will take 450 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-7 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboSingle ascending-dose study: on day1, subjects will take 600 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-8 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboArm 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. |
| Dose group-9 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboMultiple ascending-dose study: Day1-Day14 , subjects will take 70 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
| Dose group-10 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboMultiple ascending-dose study: Day1-Day14 , subjects will take 150 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
| Dose group-11 | Sham comparator | Drug: HEC169584 capsule, Drug: placeboMultiple ascending-dose study: Day1-Day14 , subjects will take 300 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects should understand and abide by the research procedures, volunteer to participate, and sign the informed consent form.
- When signing the informed consent form, subjects should be between 18 and 45 years old (including the boundary values), and both genders are eligible.
- Male subjects should weigh ≥ 50.0 kg, and female subjects should weigh ≥ 45.0 kg. For the single - dose trial, the body mass index [BMI = weight (kg) / height² (m²)] should be within the range of 18.0 - 28.0 kg/m² (including the boundary values). For the multiple - dose trial, the BMI should be within the range of 18.0 - 30.0 kg/m² (including the boundary values).
- Subjects enrolled in the MAD (Multiple - Ascending - Dose) trial should also meet the requirement that 2.6 mmol/L (100 mg/dL) ≤ LDL - C < 4.1 mmol/L (160 mg/dL).
- The results of vital signs, physical examinations, clinical laboratory tests, electrocardiograms, chest X - rays (posteroanterior view), abdominal color Doppler ultrasounds, etc. should be normal, or if judged as abnormal by the investigator, they should be of no clinical significance.
Key exclusion criteria (21 listed)
- Subjects had clinically significant diseases as follows (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, mental, or cardiovascular and cerebrovascular diseases) before screening.
- Subjects with allergic constitution (allergic to multiple drugs or foods).
- Subjects who smoked more than 5 cigarettes per day on average within 3 months before screening, or smoked within 48 hours before taking the investigational product, or could not stop using any tobacco products during the trial.
- Subjects had a history of dysphagia before screening, or had a history of gastrointestinal, hepatic, or renal diseases or surgeries that potentially affect the absorption, distribution, metabolism, and excretion of the investigational product (except uncomplicated appendectomy and hernia repair).
- Subjects had a history of alcoholism within 1 year before screening (consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or had a positive alcohol breath test during the screening period.
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 |
|---|---|---|
| HEC169584 capsuleEach dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. | Drug | Dose group-1, Dose group-10, Dose group-11, Dose group-2, Dose group-3, Dose group-4, Dose group-5, Dose group-6, Dose group-7, Dose group-8, Dose group-9 |
| placeboThe placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. | Drug | Dose group-10, Dose group-11, Dose group-2, Dose group-3, Dose group-4, Dose group-5, Dose group-6, Dose group-7, Dose group-8, Dose group-9 |
Primary outcome
Adverse event
Time frame: up to 27 days
Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.
12 secondary outcomes
PK parameters - AUC0-∞
Time frame: up to 48 hours
PK parameters - AUC0-t
Time frame: up to 48 hours
PK parameters - Cmax
Time frame: up to 48 hours
PK parameters - tmax
Time frame: up to 48 hours
PK parameters - t½
Time frame: up to 48 hours
PK parameters -Vz/F
Time frame: up to 48 hours
PK parameters -MRT
Time frame: up to 48 hours
PK parameters -CL/F
Time frame: up to 48 hours
PK parameters -The Accumulation Ratio(R)
Time frame: up to 15 days
PK parameters -Food Effect on the Cmax
Time frame: up to 48 hours
PK parameters -Food Effect on the AUC
Time frame: up to 48 hours
The pharmacodynamics of HEC169584 capsules
Time frame: Time Frame: up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
DongYang Liu, doctor principal investigator
Peking University Third 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 HEC169584 capsule in people with Non - Alcoholic Steatohepatitis, run by Sunshine Lake Pharma 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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 4 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DongYong Liu, doctor (86+18610966092, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: up to 27 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.