NCT04298749已完成1 期
A Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-P1 After Single IV Infusion in Healthy Male Volunteers
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
- Safety and tolerability as measured by AEs
研究概览
简要总结
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
- •Healthy male volunteers aged 19-45 years within screening periods
- •Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
- •Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing
排除标准
- •Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
- •History of or current disease evidence including malignant tumor
- •History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
- •Have participated in another clinical trial with investigational drug within 180 days prior to screening period
- •Positive for HCV antibody, HBsAg, or HIV antibody at screening period
- •Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator
研究组 & 干预措施
GX-P1 dose level 1
Experimental
GX-P1 dose level 1
干预措施: GX-P1 or Placebo (dose level 1) (Drug)
GX-P1 dose level 2
Experimental
GX-P1 dose level 2
干预措施: GX-P1 or Placebo (dose level 2) (Drug)
GX-P1 dose level 3
Experimental
GX-P1 dose level 3
干预措施: GX-P1 or Placebo (dose level 3) (Drug)
结局指标
主要结局
Safety and tolerability as measured by AEs
时间窗: up to 8 weeks
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
次要结局
- T1/2, Elimination half life of GX-P1(up to 4 weeks)
- Change in number of T cells(up to 4 weeks)
- AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time(up to 4 weeks)
- Cmax, Maximum observed concentration(up to 4 weeks)
- Tmax, Time to maximum observed concentration(up to 4 weeks)
- Incidence of Treatment Emergent anti-drug antibody(ADA) formation(up to 8 weeks)
研究者
研究点 (1)
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