Actively Recruiting
A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-27
96
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
CONDITIONS
Official Title
A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must understand and agree to follow the study procedures and sign informed consent
- Age between 18 and 45 years old, inclusive
- Both males and females are eligible
- Male participants must weigh at least 50 kg; female participants at least 45 kg
- BMI between 18.0 and 28.0 kg/m² for single-dose trial; BMI between 18.0 and 30.0 kg/m² for multiple-dose trial
- LDL-C level between 2.6 mmol/L and less than 4.1 mmol/L for multiple-dose trial participants
- Normal vital signs, physical exam, lab tests, ECG, chest X-ray, and abdominal ultrasound or abnormalities of no clinical significance
- Participants and their partners must use effective contraception from screening until 3 months after last dose and have no plans for sperm or egg donation
You will not qualify if you...
- History of significant diseases including gastrointestinal, renal, hepatic, neurological, hematological, endocrine, cancer, pulmonary, immune, mental, cardiovascular, or cerebrovascular conditions
- Allergic to multiple drugs or foods
- Smoking more than 5 cigarettes per day within 3 months before screening or unable to stop tobacco use during the trial
- History of swallowing difficulties or gastrointestinal, liver, or kidney diseases or surgeries affecting drug processing (except uncomplicated appendectomy or hernia repair)
- History of alcoholism within 1 year before screening or positive alcohol breath test
- History of drug abuse within 2 years before screening or positive urine drug screening
- Blood donation or loss of 400 mL or more within 3 months before screening or planned donation within 1 month after trial
- History of thyroid diseases or abnormal thyroid test results
- Corrected QT interval over 450 ms on ECG during screening
- Glomerular filtration rate less than 90 mL/min
- Vaccination within 1 month before screening or planned during the trial
- Use of certain enzyme inhibitors or inducers within 4 weeks before screening
- Use of prescription, over-the-counter, vitamin, or herbal products within 14 days before screening
- Consumption of chocolate, caffeine, xanthine, alcohol, or grapefruit within 48 hours before first dose
- Acute illness or medications from screening until before first dose
- History of fainting at sight of needles or difficulty with blood collection
- Pregnant or lactating women or positive pregnancy test in women of childbearing potential
- Participation in other clinical trials within 3 months before screening (unless withdrew before treatment)
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Special dietary requirements incompatible with study diet
- Other factors making participation inappropriate as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
No. 49, Huayuan North Road, Haidian District, Beijing Municipality
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
D
DongYong Liu, doctor
CONTACT
F
FangFang Wang, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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