NCT00612196已完成1 期
A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously 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
- 56
- 试验地点
- 1
研究概览
简要总结
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
- •No clinically important abnormal physical, laboratory, ECG findings
- •Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)
排除标准
- •Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
- •Any autoimmune disease.
- •Previous allergic reaction to immunoglobulin.
- •Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
- •Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
- •Abnormal platelet function or clinically significant out of range values for any coagulation tests.
- •History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
- •Screening FVIII:C < 50%.
研究组 & 干预措施
1
Experimental
干预措施: TB-402 (Drug)
2
Experimental
干预措施: TB-402 (Drug)
3
Experimental
干预措施: TB-402 (Drug)
4
Experimental
干预措施: TB-402 (Drug)
5
Experimental
干预措施: TB-402 (Drug)
6
Experimental
干预措施: TB-402 (Drug)
7
Experimental
干预措施: TB-402 (Drug)
8
Experimental
干预措施: TB-402 (Drug)
9
Experimental
干预措施: TB-402 (Drug)
10
Placebo Comparator
干预措施: Placebo (Drug)
研究者
研究点 (1)
Loading locations...
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