A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects

NCT07099118 | Recruiting Phase 1 DMC

• 1 other identifier: HEC169584-NASH-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .

Conditions

Non - Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Adverse event

  Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.

  up to 27 days

Secondary Outcomes (12)

• PK parameters - AUC0-∞

  up to 48 hours

• PK parameters - AUC0-t

  up to 48 hours

• PK parameters - Cmax

  up to 48 hours

• PK parameters - tmax

  up to 48 hours

• PK parameters - t½

  up to 48 hours

Other Outcomes (1)

• C-QT study, drug metabolism and excretion, drug - drug interaction characteristics (if necessary), pharmacogenomic characteristics (if necessary)

  up to 28 days

Study Arms (11)

Dose group-1

EXPERIMENTAL

On day1 subjects will take the experiment drug on an empty stomach with 240ml warm water.

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 ;

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.

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.

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

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.

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.

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.

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.

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.

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.

Drug: HEC169584 capsule; Drug: placebo

Interventions

HEC169584 capsule DRUG

Each dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

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

placebo DRUG

The placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

No. 49, Huayuan North Road, Haidian District, Beijing Municipality

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• DongYang Liu, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DongYong Liu, doctor

CONTACT

86+18610966092; liudongyang@vip.sina.com

FangFang Wang, doctor

CONTACT

86+13810103141; doctorfancy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ascending Single and Multiple Dose Study is Double-blind design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 1, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 6, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)