NCT05894148已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
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
- 24
- 试验地点
- 1
- 主要终点
- The frequency of adverse events (AE)
研究概览
简要总结
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
详细描述
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
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
- Triple (Participant, 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
- •18 years ≤ age ≤45 years, and in good health;
- •body mass index is within the range of 19 - 26 kg/m^2 (including 19 kg/m^2 and 26 kg/m^2);
- •No parental scheme from the screening period to 3 months after the study period.
排除标准
- •Participants have abnormal physical and auxiliary examination results with clinical significance;
- •History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
- •Participants who use any prescription drugs within 2 weeks prior dosing.
- •Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
- •Participation in any clinical investigation within 3 months prior to dosing;
- •Donation or loss of 400 mL or more of blood within 3 months prior to dosing;
- •Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
- •Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
- •Current or previous drug or alcohol abuse;
- •Other conditions in which the investigator preclude enrollment into the study
研究组 & 干预措施
Genakumab injection
Experimental
Group 1: 120mg，group 2: 200mg
干预措施: Genakumab injection (Drug)
placebo
Placebo Comparator
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
干预措施: placebo (Drug)
结局指标
主要结局
The frequency of adverse events (AE)
时间窗: Up to 20 weeks
adverse events during the study are to assess the safety of Genakumab.
次要结局
- Maximum observed serum Genakumab concentration(up to 20 weeks)
- Area under the serum Genakumab concentration-time curve(up to 20 weeks)
研究者
研究点 (1)
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