NCT01542619已完成1 期
A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The frequency of related Adverse Events (AEs) to rVIIa-FP.
研究概览
简要总结
This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.
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 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18 and 35 years of age, both inclusive.
- •Body weight between 50.0 and 100.0 kg, both inclusive.
- •Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
- •Written informed consent for study participation obtained before undergoing any study specific procedures.
排除标准
- •Subjects at increased cardiovascular risk.
- •Any clinical sign or known history of atherosclerosis or thromboembolic events.
- •A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
- •Subjects with significant elevation of cholesterol level.
- •Renal dysfunction.
- •Overt bleeding.
- •Smokers with positive cotinine test at screening.
- •Participation in any other trial investigating a procoagulant within the last six months prior to screening.
- •Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
- •Contraindications to Warfarin (Coumadin®).
结局指标
主要结局
The frequency of related Adverse Events (AEs) to rVIIa-FP.
时间窗: 28 days
Number of subjects who develop inhibitors against Factor VII (FVII).
时间窗: 28 days
Number of subjects who develop antibodies against rVIIa-FP.
时间窗: 28 days
次要结局
- Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP(120 hours)
- Half- life (t1/2) of a single dose of rVIIa-FP(120 hours)
- Incremental recovery (IR) of rVIIa-FP(120 hours)
- Clearance (Cl) of a single dose of rVIIa-FP(120 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT01878123MedImmune LLC26
招募中
1 期
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy WomenVaginitisVaginal DiseaseBacterial InfectionsInfection, BacterialBacterial VaginosisNCT05587283AtoGen Co. Ltd24
已完成
1 期
A Study of XW001 in Healthy Adult SubjectsRespiratory Syncytial Virus InfectionsNCT05642403Hangzhou Sciwind Biosciences Co., Ltd.81
已完成
1 期
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseMultiple Sclerosis, Acute RelapsingNCT02398461Acorda Therapeutics27
已完成
1 期
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese ParticipantsAcute Bacterial Skin and Skin Structure Infection (ABSSSI)Prosthetic Joints Infection (PJI)NCT06394518TenNor Therapeutics Inc.32