NL-OMON51966已完成不适用
A Phase 1/2 study of the dose-response in pharmacodynamics and safety of prothrombin complex concentrate Cofact in healthy subjects under vitamin K antagonist anticoagulation - Dose response in PD and safety of Cofact under VKA anticoagulation
Prothya Biosolutions BV0 个研究点目标入组 85 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Sex: Male or female of nonchildbearing potential.
- •2. Age: 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI):18.0 to 30.0 kg/m2, inclusive, at screening. Body
- •weight is not less than 50 kg and not more than 100 kg.
- •4. Status: Healthy subjects.
- •5. Female subjects will be included if they are of nonchildbearing potential.
- •Female subjects should have a documented history of tubal ligation more than 6
- •months prior to the onset of the study, or with a documented hysterectomy.
- •Postmenopausal women will be included in the study if the postmenopausal status
- •is confirmed with a history of 12 months uninterrupted spontaneous amenorrhea,
- •or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone
- •(FSH) levels >40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with
- •or without hysterectomy.
- •6. Male subjects, if not surgically sterilized, must agree to use adequate
- •contraception and not donate sperm from first admission to the clinical
- •research center until 90 days after the follow-up visit. Adequate contraception
- •for the male subject (and his female partner, if she is of childbearing
- •potential) is defined as using hormonal contraceptives or an intrauterine
- •device combined with at least 1 of the following forms of contraception: a
- •diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual
- •intercourse, in accordance with the lifestyle of the subject, is also
- •acceptable.
- •Further criteria apply, see protocol.
排除标准
- •1. Employee of PRA or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. Any of the following laboratory results outside of the ranges, at screening:
- •lupus anticoagulants (LA screen) and/or anti-beta2-glycoprotein I, low levels
- •of protein C (activity), low levels of protein S (activity), or low levels of
- •antithrombin.
- •4. Abnormal aPTT or PT levels, or Fe or ferritin levels.
- •5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma
- •glutamyl transferase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase
- •(ALP), and total bilirubin are not more than about 1.2 times the upper limit of
- •normal at screening (per the Investigator*s discretion).
- •Further criteria apply, see protocol.
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