A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AE)
研究概览
简要总结
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
详细描述
This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.
The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.
Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.
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
- 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
- •Age of 18 to 55 years, inclusive, male or female
- •BMI between 19 kg/m2 and 26 kg/m2 (inclusive)
- •Healthy volunteers
排除标准
- •History of chronic disease or serious disease
- •Subject with severe psychological or mental illness
- •Not enough washing-out period for previous therapy
结局指标
主要结局
Incidence of Adverse Events (AE)
时间窗: 85 days
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
次要结局
- Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)(85 days)
- Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)(85 days)
- Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)(85 days)
- Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration(85 days)