Actively Recruiting
Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects
Led by Shanghai Kechow Pharma, Inc. · Updated on 2025-03-10
52
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender.
- Males must weigh 6550 kg, and females must weigh 6545 kg.
- Body Mass Index (BMI) should be within the range of 19 to 26 kg/m�b2 (including threshold values).
- Serum creatinine levels must be within normal range and Creatinine Clearance (CCr) 6590 mL/min (using CKD-EPI formula).
- Physical exam, vital signs, 12-lead ECG, chest X-ray, and labs must show no significant abnormalities.
- Must agree to avoid pregnancy during the trial and for 3 months after using reliable contraception.
- Must communicate effectively, understand the trial, voluntarily consent, and complete the trial per protocol.
You will not qualify if you...
- Known allergy to the study drug or related components, or hypersensitivity.
- Special dietary requirements preventing standardized meals.
- History of frequent nausea or vomiting.
- QTcF interval >450 msec.
- Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody.
- Consumed caffeine-rich foods/beverages within 48h before dosing or unwillingness to abstain.
- Medical conditions affecting safety or drug metabolism including CNS, cardiovascular, digestive, respiratory, urinary, hematologic, immunologic, psychiatric disorders, metabolic abnormalities, or gastrointestinal surgery (except appendectomy).
- Blood loss >400 mL or blood transfusion within 3 months; blood donation >200 mL within 1 month.
- Use of CYP3A4/CYP2C9/CYP2C8 inhibitors/inducers within 30 days; prescription/OTC/herbal meds within 14 days.
- Participation in other drug trials within 3 months.
- Drug addiction or positive drug abuse screening.
- Excessive alcohol (>14 units/week) or unwillingness to abstain.
- Heavy smoking (>5 cigarettes/day) or unwillingness to abstain.
- Consumption of grapefruit/pomelo/lime products within 48h or refusal to abstain.
- Poor compliance or investigator-determined unsuitability.
- For females: oral contraceptive use within 30 days or long-acting estrogen/progestin use within 6 months; unprotected intercourse within 14 days; pregnancy or lactation.
- Directly involved research staff or family members.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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