A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Voluteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and serious adverse events
研究概览
简要总结
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy voluteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy voluteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understanding and Signing a written informed consent prior to selection;
- •Aged above 18 years old, male or female;
- •Body mass index (BMI) between 18-28kg/m2;
- •Normal lable test;
- •No parenting plan for at least 6 months
排除标准
- •Subjects with a history of allergy；
- •Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- •Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- •HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- •There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
- •Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
- •Subject with a hcg positive;
- •Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
研究组 & 干预措施
IBI355 dose-3
IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: placebo (Drug)
IBI355 dose-3
IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: IBI355 (Drug)
IBI355 dose-1
IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: placebo (Drug)
IBI355 dose-1
IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: IBI355 (Drug)
IBI355 dose-4
IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: placebo (Drug)
IBI355 dose-4
IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: IBI355 (Drug)
IBI355 dose-2
IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: placebo (Drug)
IBI355 dose-2
IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
干预措施: IBI355 (Drug)
结局指标
主要结局
Incidence of adverse events and serious adverse events
时间窗: Up to week 24
次要结局
- Half-life (t1/2) of multi-dose of IBI355(Up to week 12)
- The ratio of Anti-drug antibody of multi-dose of IBI355(Up to week 24)
- Area under the Curve(AUC) of multi-dose of IBI355(Up to week 12)
- Clearance (CL) of multi-dose of IBI355(Up to week 12)
- Peak serum concentration(Cmax) of multi-dose of IBI355(Up to week 12)