NCT01042964已完成1 期
An Open-Label, Dose-Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of PR-15, an Inhibitor of Platelet Adhesion, in Six Different Strengths in Healthy Male Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
研究概览
简要总结
Primary objective:
To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers
详细描述
Primary objective:
To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), bleeding time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy, male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male Caucasians between 18 and 45 years of age.
- •Normotensive subjects (systolic BP < 140 mmHg and diastolic BP <90 mmHg;
- •Body weight of 70 to 90 kg (BMI 20 -
- •Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests;
- •Signed Informed Consent Form.
- •Normal coagulation function (aPTT between 24 and 35 seconds, PT between 70 and 130%, INR between 0.85 and 1.15.
排除标准
- •Subjects who are taking or have taken any prescription medication within the last 14 days or any non-prescription medication, especially, anti-platelet drugs, within the last seven days prior to the administration of trial medication on Day
- •Intake of any investigational drug within three months prior to the administration of study medication on Day
- •Concomitant use of any other medication including over-the-counter preparations.
- •History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation or hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug.
- •A history or clinical evidence of any cardiac, cardio- or cerebrovascular, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, haematological, oncological or psychiatric disease or emotional problems or any other clinically relevant condition, physical finding, ECG- or laboratory test abnormality, which - in the opinion of the investigator - would pose a significant risk for the subject, invalidate the Informed Consent or limit the ability of the subject to comply with study requirements or interfere otherwise with the conduct of the study.
- •Any laboratory value outside the normal laboratory reference range at Screening and before randomization, unless approved by the investigator.
- •Subjects known to have experienced elevated liver enzyme values will also be excluded.
- •History of alcohol and/or drug abuse (verified by drug screening).
- •Blood loss of 450 ml or more during the last three months before Screening.
- •Subjects who smoke more than 5 cigarettes per day and/or are unable to abstain from smoking during the entire in-house period.
- •Subjects who were previously enrolled in this trial or who have received PR-15 in a previous trial.
- •Subjects who have participated in other clinical trials in the last 3 months.
结局指标
主要结局
safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
时间窗: 43 days
次要结局
- pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)(43 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 SkippingDuchenne Muscular DystrophyNCT03218995Sarepta Therapeutics, Inc.15
终止
1 期
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)Solid TumorUrothelial CancerEndometrial CancerMyeloproliferative NeoplasmsBreast CancerLung CancerMultiple MyelomaGastric CancerCholangiocarcinomaMPNUCNCT02393248Incyte Corporation201
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult VolunteersHealthyNCT04601844Regeneron Pharmaceuticals19
已完成
1 期
Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple MyelomaMultiple MyelomaNCT00963820Millennium Pharmaceuticals, Inc.60
已完成
1 期
Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia ASevere Hemophilia ANCT01027377Bioverativ Therapeutics Inc.16