A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
研究概览
简要总结
This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects
详细描述
In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.
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
- Double (Participant, Investigator)
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
- •Healthy male or female 18 to 45 years of age at the time of consent
- •BMI of 19-26Kg/m2 and weight of 50-100kg
- •Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements
排除标准
- •Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine
- •Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks;
- •Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs;
- •Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
- •Subjects who are not suitable for this trial due to other reasons In the investigator' opinion
研究组 & 干预措施
Cohort 1
IBI112 SC dose1
干预措施: IBI112 dose1 (Drug)
Cohort 2
IBI112 SC dose2
干预措施: IBI112 dose2 (Drug)
Cohort 3
IBI112 SC dose3
干预措施: IBI112 dose3 (Drug)
Cohort 4
IBI112 IV dose4
干预措施: IBI112 dose4 (Drug)
Cohort 5
IBI112 IV dose3
干预措施: IBI112 dose5 (Drug)
Cohort 6
IBI112 SC dose5
干预措施: IBI112 dose6 (Drug)
Cohort 7
IBI112 IV dose5
干预措施: IBI112 dose7 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
时间窗: Day1 to Day 113 post dose
次要结局
- Volume of Distribution (Vd) - Pharmacokinetic Assessment(Day 113)
- Maximum Concentration (Cmax) - Pharmacokinetic Assessment(Day 113)
- Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment(Day 113)
- Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment(Day 113)
- Half-Life (t1/2) - Pharmacokinetic Assessment(Day 113)