Evaluating the safety and pharmacokinetics of HL-003 tablets in healthy individuals
Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects
This study is testing the safety and how the body processes HL-003 tablets in healthy people to see if they can be a good option for future treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Shanghai Kechow Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06867393 on ClinicalTrials.gov |
What this trial studies
This clinical study assesses the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects through a two-phase approach. The first phase involves a single-dose escalation trial that is randomized, double-blind, and placebo-controlled. Following this, a multiple-dose escalation phase will be conducted, adjusting dosage and frequency based on initial results. The study aims to gather comprehensive data on how HL-003 is processed in the body and its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 50 who meet specific weight and BMI criteria.
Not a fit: Patients with underlying health conditions or those outside the specified age and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of HL-003, potentially leading to its use in future therapeutic applications.
How similar studies have performed: Other studies evaluating the safety and pharmacokinetics of new drugs in healthy subjects have shown success, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.