NCT06867393招募中1 期
Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-related adverse events (TRAEs) that were intolerable (requiring intervention)
研究概览
简要总结
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.
详细描述
The single-dose escalation clinical trial of HL-003 tablets is designed as a dose-escalation, randomized, double-blind, placebo-controlled, parallel-group study.
The multiple-dose clinical trial of HL-003 tablets is designed as a randomized, double-blind, placebo-controlled, parallel-group study. The specific dosage, dosing frequency, and duration of continuous administration will be adjusted based on the results of the single-dose escalation clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
- •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.
排除标准
- •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);
- •Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody;
- •Consumption of caffeine-rich foods/beverages within 48h before dosing, or unwillingness to abstain during the study;
- •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);
- •Blood loss ≥400 mL or blood transfusion within 3 months before dosing; Blood donation (including component donation) ≥200 mL within 1 month before dosing;
- •Use of CYP3A4/CYP2C9/CYP2C8 inhibitors/inducers within 30 days before dosing; Any prescription/OTC medications/herbal products within 14 days before dosing;
- •Participation in other drug trials within 3 months before dosing;
- •Current/past drug addiction or positive drug abuse screening;
- •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;
- •Heavy smoking (>5 cigarettes/day within 3 months) or inability to abstain during the study;
- •Consumption of CYP-affecting foods (grapefruit/pomelo/lime products) within 48h before dosing, or refusal to abstain during the study;
- •Poor compliance or other investigator-determined unsuitable factors;
- •Additional female exclusions:
- •Oral contraceptive use within 30 days before screening or during study
- •Long-acting estrogen/progestin use within 6 months before screening
- •Unprotected intercourse within 14 days before study or during trial
- •Pregnancy or lactation;
- •Directly involved research staff or their family members, or subordinate researchers.
研究组 & 干预措施
HL-003 tablet Placeco
Placebo Comparator
干预措施: HL-003 tablet Placeco (Drug)
HL-003 tablet
Active Comparator
干预措施: HL-003 tablet (Drug)
结局指标
主要结局
Incidence and severity of treatment-related adverse events (TRAEs) that were intolerable (requiring intervention)
时间窗: up to 3 days
Incidence of TEAEs
时间窗: up to 3 days
次要结局
- Pharmacokinetic (PK) parameters: Tmax(up to 3 days)
- Pharmacokinetic (PK) parameters: Cmax(up to 3 days)
- Pharmacokinetic (PK) parameters: AUC0-t(up to 3 days)
- Pharmacokinetic (PK) parameters: AUC0-inf(up to 3 days)
- Pharmacokinetic (PK) parameters: t1/2(up to 3 days)
- Pharmacokinetic (PK) parameters: CL/F(up to 3 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of LymphomaRecurrent or Refractory B-cell Non Hodgkin's LymphomaNCT06503211The First Affiliated Hospital with Nanjing Medical University10
已完成
1 期
Study to Assess PK, Safety and Tolerability in Healthy SubjectsAcute Ischemic StrokeNCT06380699Changzhou Qianhong Bio-pharma Co., Ltd.56
已完成
1 期
A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular DegenerationNeovascular Age-Related Macular DegenerationNCT03387566Huabo Biopharm Co., Ltd.21
已完成
1 期
A Study of Injection HB002.1T in Subjects With Solid TumorSolid TumorNCT03636750Huabo Biopharm Co., Ltd.27
招募中
1 期
Phase 1 Clinical Study of JMKX003142 TabletsSafety and TolerabilityNCT06079541Jemincare106