The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
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).
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).
Parallel
HEC169584 capsule
DrugEach dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
placebo
DrugThe placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
11
Treatment groupsSee each treatment group below.
Adverse event
Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
PK parameters - AUC0-t
Area under the concentration versus time curve (AUC) from time zero to 48 h (AUC0-48 )
PK parameters - Cmax
Maximum Plasma Concentration ( Cmax)
PK parameters - tmax
Time to peak(tmax)
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).
Click on the lead sponsor to view all of their trials.
