NCT02146625已完成1 期
A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Pharmacokinetics: AUC, Cmax
研究概览
简要总结
The objectives of this study are:
- To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers in the age between 19 and 45 years old (inclusive)
- •Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg
- •Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial
排除标准
- •History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
- •History of allergy or sensitivity to any drug
- •Subject with the following clinically significant laboratory abnormalities:
- •AST or ALT > 1.25 x Upper Limit Normal (ULN)
- •Total bilirubin > 1.5 x Upper Limit Normal (ULN)
- •CPK > 1.5 x Upper Limit Normal (ULN)
- •eGFR < 60 mL/min/1.73 m2
- •Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
- •History of drug abuse
- •History of caffeine, alcohol, smoking abuse
- •Participation in any clinical investigation within 60days prior to study medication dosing
- •Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
- •Positive test results for HBs Ab, HCV Ab, HIV test
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Dose level 1 of CJ-40002
Experimental
- Single dose
- 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
干预措施: CJ-40002 (Drug)
Dose level 2 of CJ-40002
Experimental
- Single dose
- 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
干预措施: CJ-40002 (Drug)
Dose level 3 of CJ-40002
Experimental
- Single dose
- 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
干预措施: CJ-40002 (Drug)
Dose level 4 of CJ-40002
Experimental
- Single dose
- 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
干预措施: CJ-40002 (Drug)
Dose level 5 of CJ-40002
Experimental
- Single dose
- 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
干预措施: CJ-40002 (Drug)
结局指标
主要结局
Pharmacokinetics: AUC, Cmax
时间窗: 15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
时间窗: 29 days
次要结局
- Pharmacokinetics: Tmax, T1/2, CL/F, Vd(15 days)
- Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP(15 days)
- Formation of anti-drug antibodies(29 days)
研究者
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