A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups
详细描述
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.
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
- Quadruple (Participant, Care Provider, 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
- •Healthy adult subjects
- •Signed informed consent
排除标准
- •History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- •Prior use of drug targeting TNF-like cytokine 1A
- •history of malignant tumor
- •psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
研究组 & 干预措施
group 5
single dose
干预措施: Placebo (Biological)
group 6
multiple dose
干预措施: GR2303 injection (Biological)
group 6
multiple dose
干预措施: Placebo (Biological)
group 7
multiple dose
干预措施: GR2303 injection (Biological)
group 7
multiple dose
干预措施: Placebo (Biological)
group 8
multiple dose
干预措施: GR2303 injection (Biological)
group 8
multiple dose
干预措施: Placebo (Biological)
group 5
single dose
干预措施: GR2303 injection (Biological)
group 1
single dose
干预措施: GR2303 injection (Biological)
group 1
single dose
干预措施: Placebo (Biological)
group 2
single dose
干预措施: GR2303 injection (Biological)
group 2
single dose
干预措施: Placebo (Biological)
group 3
single dose
干预措施: GR2303 injection (Biological)
group 3
single dose
干预措施: Placebo (Biological)
group 4
single dose
干预措施: GR2303 injection (Biological)
group 4
single dose
干预措施: Placebo (Biological)
结局指标
主要结局
Adverse events
时间窗: 16 weeks
次要结局
- ADA(16 weeks)
- t 1/2(16 weeks)
- Cmax(16 weeks)
- Tmax(16 weeks)