DRKS00004400已完成1 期
Clinical Phase I study to assess safety tolerability, pharmacokinetics and pharmacodynamics of ATROSAB (Anti-TNF-receptor 1 monoclonal antibody) in response to single ascending intravenous infusion doses. A single center, randomized, double blind, parallel group and placebo-controlled clinical trial in healthy male subjects - ATR 001
Baliopharm GmbH0 个研究点目标入组 27 人开始时间: 2012年10月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Healthy male volunteers who agree to use appropriate contraception methoids; age 18-45 years
排除标准
- •1. Positive test for HIV antibodies, hepatitis B-virus surface antigen (HbsAg), anti-hepatitis-C virus antibodies (Anti-HCV) or no performed test.
- •2. Subjects with febrile or infectious illness within the last 7 days prior to administration of the IMP.
- •3. Subjects demonstrating any active physical disease, acute or chronic.
- •4. History of alcohol or drug abuse.
- •5. Subjects who have consumed ethanol within 48 hours prior to IMP administration.
- •6. More than moderate alcohol consumption (> 20 g of ethanol regularly per day or > 245 g regularly per week).
- •7. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse.
- •8. Heavy smoker (> 10 cigarettes per day) and unable to stop smoking during hospitalization
- •9. History of known hypersensitivity or allergy to monoclonal antibodies or excipients used in the formulation.
- •10. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
- •11. Consumption of xanthine-containing food or beverages as well as grapefruit juice within 48 hours prior to study drug administration.
- •12. Strictly vegetarians or vegans.
- •13. Any cardiovascular diseases or atrioventricular (AV) block (PQ time > 220 ms and/or QTcB > 450 ms at rest).
- •14. Antibiotic therapy for more than 7 days during the last 3 months.
- •15. Participation in any other clinical study or donation of more than 400 ml blood during the last 90 days before IMP administration.
- •16. History of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal (e.g., gastric and intestinal ulcer, cholecystectomy), neurological (especially history of epileptic seizures), endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency.
- •17. Unexplained weight loss or weight gain of more than 5 kg in the month prior to the study.
- •18. Subjects on a weight reduction program or a medically supervised diet.
- •19. Use of any medication (self-medication or prescription medication) within one week before IMP administration (or at least 10 times the respective elimination half-life, whichever is longer).
- •20. Subjects with latent TB (as diagnosed by Quantiferon test).
- •21. Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after administration of the study drug.
- •22. Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents.
- •23. Participation in this study on a previous dose level.
- •24. Subjects who are aware of having had contact to TBC (tuberculosis) patients within the last 3 months.
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