Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects

Launched by SHANGHAI KECHOW PHARMA, INC. · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HL-003 to see how safe it is and how well it is tolerated by healthy volunteers. The trial will take place in two parts: one where participants take a single dose of the medication and another where they take multiple doses over time. The researchers want to understand how the body processes the medication and if there are any side effects.

To be eligible for this trial, participants should be healthy adults aged between 18 and 50, with a specific weight and body mass index (BMI) range. They must also pass certain health tests and agree to use reliable birth control during the study. Participants can expect to undergo various health assessments, including physical exams and lab tests, to ensure they are suitable for the trial. It's important to note that individuals with certain medical histories or those taking specific medications may not qualify. If you or someone you know is interested, it’s a good idea to discuss it with a healthcare professional to understand more about participation and any related commitments.

Gender

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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 methods.
• • 6. Participants must be able to communicate effectively with researchers, fully understand the purpose, methods, requirements, and potential adverse reactions of the trial, voluntarily participate in the clinical trial, sign a written informed consent form, and be able to complete the clinical trial according to the protocol requirements.
• Exclusion Criteria:
• • 1. 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;
• • 2. Subjects with special dietary requirements who cannot comply with standardized meals;
• • 3. History of frequent nausea or vomiting from any cause;
• • 4. QTcF interval \>450 msec (calculation formula in Appendix 14-3);
• • 5. Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody;
• • 6. Consumption of caffeine-rich foods/beverages within 48h before dosing, or unwillingness to abstain during the study;
• • 7. Any medical history/comorbidities that may affect safety assessment or drug metabolism, including CNS, cardiovascular, digestive, respiratory, urinary, hematologic, immunological, psychiatric disorders, metabolic abnormalities, or gastrointestinal surgery (except appendectomy);
• • 8. Blood loss ≥400 mL or blood transfusion within 3 months before dosing; Blood donation (including component donation) ≥200 mL within 1 month before dosing;
• • 9. Use of CYP3A4/CYP2C9/CYP2C8 inhibitors/inducers within 30 days before dosing; Any prescription/OTC medications/herbal products within 14 days before dosing;
• • 10. Participation in other drug trials within 3 months before dosing;
• • 11. Current/past drug addiction or positive drug abuse screening;
• • 12. Excessive alcohol consumption (\>14 units/week; 1 unit=360mL beer/45mL 40% liquor/150mL wine) within 3 months or unwillingness to abstain during the study;
• • 13. Heavy smoking (\>5 cigarettes/day within 3 months) or inability to abstain during the study;
• • 14. Consumption of CYP-affecting foods (grapefruit/pomelo/lime products) within 48h before dosing, or refusal to abstain during the study;
• • 15. Poor compliance or other investigator-determined unsuitable factors;
• 16. Additional female exclusions:
• • 1. Oral contraceptive use within 30 days before screening or during study
• • 2. Long-acting estrogen/progestin use within 6 months before screening
• • 3. Unprotected intercourse within 14 days before study or during trial
• • 4. Pregnancy or lactation;
• • 17. Directly involved research staff or their family members, or subordinate researchers.