Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects
Trial Parameters
Brief Summary
This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation.
Eligibility Criteria
Inclusion Criteria: 1. Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender. 2. Males must weigh ≥50 kg, and females must weigh ≥45 kg. The Body Mass Index (BMI) should be within the range of 19 to 26 kg/m² (including the threshold values). 3. Serum creatinine levels must be within the normal range during the screening period, and the Creatinine Clearance (CCr) must be ≥90 mL/min (including the threshold value, calculated using the CKD-EPI formula. 4. Comprehensive physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), and laboratory tests (including blood routine, blood biochemistry, thyroid function, parathyroid function, coagulation function, urinalysis, etc.) must all be within normal ranges or show no clinically significant abnormalities. 5. Participants must agree not to plan for pregnancy during the trial and for 3 months after taking the medication, and must use reliable contraceptive meth