Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects
ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Kechow Pharma, Inc.
About this trial
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
Qualifiers
Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender.
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).
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.
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.
Disqualifiers
History of known allergy to the investigational drug or any of its components/related formulations; history of allergic reactions to two or more medications, foods, etc., or individuals with hypersensitive constitution;
Subjects with special dietary requirements who cannot comply with standardized meals;
History of frequent nausea or vomiting from any cause;
QTcF interval >450 msec (calculation formula in Appendix 14-3);
Trial design
Treatments tested in this trial
- HL-003 tablet Placeco
- HL-003 tablet
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov