NCT00846274已完成1 期
Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ATIII activity
研究概览
简要总结
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •ages 19 to 40
- •Body weight: More than 50kg
- •Healthy male subject
排除标准
- •Hb<14g/dL, Hct<42%
- •ATIII hypersensitivity
结局指标
主要结局
ATIII activity
时间窗: within 20min after injection ATIII
次要结局
- ATIII antigen(within 20min after injection ATIII)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's DiseaseCrohn's DiseaseNCT02148185Mitsubishi Tanabe Pharma Corporation1
已完成
1 期
Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy VolunteersPharmacokineticsNCT03522012Mycenax Biotech Inc.190
进行中（未招募）
1 期
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese SubjectsEGFR OverexpressionNCT06309043Shanghai Henlius Biotech268
Unknown
1 期
A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and USlicensed Avastin®.Healthy VolunteersNCT04408989mAbxience Research S.L.114
已完成
1 期
A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese ParticipantsHealthy VolunteersNCT03276052AstraZeneca20