NCT01191372终止1 期
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Baxalta now part of Shire0 个研究点目标入组 17 人开始时间: 2010年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 主要终点
- Pharmacokinetics (PK) of ARC19499
研究概览
简要总结
The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male patients ≥18 to ≤75 years of age.
- •Hemophilia of any type or severity.
- •Patients who are negative for hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV) I and II antibody tests at screening.
- •Male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment.
- •All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.
排除标准
- •Female patients;
- •If on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study.
- •Existence of other co-existing bleeding disorder (e.g., von Willebrand Disease).
- •Medical history of venous or arterial thromboembolism.
- •Scheduled for elective surgical procedure during the conduct of this study.
- •Use of an investigational drug within 30 days of study entry.
- •Transaminase values > 3 x upper limit of normal (ULN) at time of screening.
- •Haemoglobin <12.0 g/dL.
- •Participants who, in the opinion of the Investigator, have a significant infection or known inflammatory process on screening.
- •Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- •Any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke.
- •Any medication the investigator considers may increase the risk of adverse effects during the study.
研究组 & 干预措施
saline for injection
Placebo Comparator
干预措施: placebo control (Drug)
ARC19499 Low Dose
Experimental
干预措施: ARC19499 (Drug)
ARC19499 Mid Dose
Experimental
干预措施: ARC19499 (Drug)
ARC19499 High Dose
Experimental
干预措施: ARC19499 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of ARC19499
时间窗: 2 weeks
The PK profile of ARC19499 administered by single and multiple subcutaneous injections will be characterized. The bioavailability of subcutaneously injected ARC19499 relative to that of intravenously infused ARC19499 will be determined.
次要结局
- Coagulation system pharmacodynamic (PD) effects of ARC19499.(2 weeks)
研究者
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