NCT03918967已完成1 期
A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
研究概览
简要总结
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:
- Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
- Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
- Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) ≥18.0 and ≤30.0 kg/m2
排除标准
- •Clinically significant allergic reactions
- •Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
- •Hepatic dysfunction upper limit of normal laboratory range
- •Cardiac history or presence
- •History or any concomitant active malignancy
- •A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •Hemoptysis, thrombotic or hemorrhagic event
- •Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
- •History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- •Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption
研究组 & 干预措施
CT-G11
Experimental
CT-G11 Experimental Drug
干预措施: CT-G11 (Drug)
CT-G20
Experimental
CT-G20 Experimental Drug
干预措施: CT-G20 (Drug)
CT-G11 Placebo
Placebo Comparator
干预措施: CT-G11 Placebo (Drug)
CT-G20 Placebo
Placebo Comparator
干预措施: CT-G20 Placebo (Drug)
结局指标
主要结局
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
时间窗: Up to 48 hours after administration
Incidence of Adverse events including serious Adverse events (Part I, Part II)
时间窗: 46 days
次要结局
- PD parameters as assessed by : Left ventricular ejection fraction (LVEF)(17 Days)
- Safety parameters as assessed by: blood pressure of Vital signs(17 Days)
- PK parameters as assessed by : Maximum observed concentration (Cmax)(13 Days)
- PK parameters as assessed by : Terminal half-life time (t1/2)(13 Days)
- Safety parameters as assessed by: clinical chemistry(17 Days)
- PK parameters as assessed by : Area under the concentration-time curve (AUC)(13 Days)
- Safety parameters as assessed by: QTcF of ECG(17 Days)
- Safety parameters as assessed by: pulse rate of Vital signs(17 Days)
- PK parameters as assessed by : Time to Cmax (tmax)(13 Days)
- Safety parameters as assessed by: QT interval of ECG(17 Days)
- Safety parameters as assessed by: body temperature of Vital signs(17 Days)
- Safety parameters as assessed by: hematology of Clinical laboratory tests(17 Days)
研究者
研究点 (1)
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