Tolerability and Pharmacokinetics of Ginkgolide B Injection Following Single- and Multiple-Ascending Doses in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AE) as assessed by CTCAE v5.0
研究概览
简要总结
To evaluate the safety and tolerability of multiple intravenous infusions of Ginkgolide B Injection in healthy Chinese participants, as well as to assess the pharmacokinetic (PK) characteristics following single and multiple doses.
详细描述
This was a single-center, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study. A total of three dose groups (low, medium, and high) were planned for the multiple-dose dose-escalation safety and tolerability study, as well as the single- and multiple-dose PK study. The dose groups were 10 mg, 20 mg, and 30 mg, with a total of 36 subjects across the three groups (12 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •.Aged 18 to 45 years (inclusive), with both males and females included;
- •.Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, and Body Mass Index (BMI) within the range of 19.0 to 26.0 kg/m² (inclusive of 19.0 and 26.0) (BMI = weight/height²);
- •.Participants have no clinically significant diseases of the cardiovascular, cerebrovascular, respiratory, renal, gastrointestinal, hepatic, metabolic, endocrine, immunological, neurological, or psychiatric systems, and are in generally good health;
- •.Agree to have no pregnancy plans and voluntarily take effective contraceptive measures, and no sperm or egg donation plans, during the study period and for at least 6 months after the last dose of the study drug;
- •.Participants fully understand the purpose, nature, methods, and possible adverse reactions of the trial, can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the Informed Consent Form.
排除标准
- •. History of multiple or recurrent allergies, or known allergy to the study drug or drugs of similar class;
- •. Suffering from coagulation dysfunction, bleeding tendency, or peptic ulcer;
- •. Vital signs measurements, physical examination, laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation function, virology, serum human chorionic gonadotropin, etc.), 12-lead electrocardiogram, chest X-ray (PA view), abdominal ultrasound, urine drug screening, and alcohol breath test show abnormalities that are deemed clinically significant by the investigator;
- •. Use of any drugs that inhibit or induce hepatic drug metabolism (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, and theophyllines) within 30 days before trial drug administration;
- •. Participation in another clinical drug trial within 3 months prior to screening;
- •. Vaccination within 1 month prior to screening, or use of any medication within 2 weeks prior to screening;
- •. Blood loss or blood donation (including blood components) exceeding 400 mL, or receipt of blood or blood component transfusion, within 3 months prior to screening;
- •. Undergone major surgery within 3 months prior to screening, or planned surgery during the study period, or undergone surgery that may affect drug absorption, distribution, metabolism, or excretion;
- •. History of drug abuse within 6 months prior to screening, or use of narcotics (e.g., cannabis, cocaine, phencyclidine) within 3 months prior to screening;
- •. Average daily smoking of more than 5 cigarettes within 3 months prior to screening;
- •. Regular alcohol consumption within 3 months prior to screening, defined as exceeding 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine with 12% alcohol content);
- •. Excessive consumption of caffeinated beverages (>4 cups/day, 1 cup = 250 mL) within 3 months prior to screening;
- •. Unwillingness to abstain from using/consuming any products containing nicotine, alcohol, caffeine, or grapefruit (e.g., cigarettes, nicotine lozenges, nicotine gum, coffee, tea, cola, Red Bull, chocolate, grapefruit, etc.) from the start of screening until the end of the trial; or unwillingness to avoid strenuous exercise from 48 hours before dosing until the end of the trial;
- •. Inability to tolerate venipuncture or history of needle phobia or syncope upon seeing blood;
- •. Special dietary requirements or inability to accept a standardized diet (including items such as milk);
- •. Use of long-acting estrogens, progestins, or contraceptives within 6 months prior to the trial; use of any hormones or contraceptives within 30 days prior to the trial; unprotected sexual intercourse with a partner within 14 days prior to the trial for females of childbearing potential;
- •. Lactating or pregnant females;
- •. Other conditions deemed by the investigator as rendering the subject unsuitable for participation in the trial
研究组 & 干预措施
Ginkgolide B Dose 1
The 10 mg dose group: infusion once daily for 7 consecutive days
干预措施: The 10mg dose group (Drug)
Ginkgolide B Dose 2
The 20mg dose group : infusion once daily for 7 consecutive days
干预措施: The 20mg dose group (Drug)
Ginkgolide B Dose 3
The 30mg dose group : infusion once daily for 7 consecutive days
干预措施: The 30mg dose group (Drug)
Placebo
The Placebo group : infusion once daily for 7 consecutive days
干预措施: The Placebo group (Other)
结局指标
主要结局
Incidence of Adverse Events (AE) as assessed by CTCAE v5.0
时间窗: From screening to day 15
The incidence, severity (graded by CTCAE v5.0), and relationship to the study drug of all adverse events (AEs), serious adverse events (SAEs), and AEs leading to study discontinuation will be recorded and summarized.
Number of Participants with Clinically Significant Changes in Laboratory Parameters
时间窗: From screening to day 15
Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes from baseline at each post-baseline visit will be summarized
Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
时间窗: From screening to day 8
Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
次要结局
- Area Under the Plasma Concentration(From pre-infusion (0 hours) to 24 hours post-infusion)
研究者
Yu Qin
Director, Office of Clinical Trial Institution
West China Second University Hospital