DRKS00007903已完成1 期
A single-center, randomized, single-blinded, controlled, pilot study to investigate the delivery of adalimumab after subcutaneous injection with a needle free injection device compared to injection with a syringe - /
IIS Innovative Injektions-Systeme GmbH & Co. KG0 个研究点目标入组 36 人开始时间: 2015年3月20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
- 36
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
- All
入选标准
- •1. Subjects who are able to understand and follow instructions during the study.
- •2. Signed informed consent.
- •3. Male or female.
- •5. Age between 18 and 45 years (inclusive).
- •6. In general good physical health as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and
- •clinical laboratory tests.
- •7. Weight within the normal range according to accepted values for the Body mass index within 18.0 to 29.4 kg/m2.
- •8. Normal blood pressure.
- •9. A heart rate above 50 or below 100 beats per min measured after at least 5 min rest in supine position.
- •10. ECG recording without clinically significant
- •abnormalities.
- •There are additional details/criteria.
排除标准
- •1. More than moderate smoker (>10 cigarettes/day).
- •2. More than moderate alcohol consumption.
- •3. Any history of alcohol or drug abuse.
- •4. Use of any medication within 2 weeks before first dosing.
- •5. Blood donation within 30 days before signing
- •informed consent to this trial.
- •6. Demonstrating any active physical disease, acute or chronic.
- •7. Any history of drug hypersensitivity, asthma,
- •urticaria or other severe allergic diathesis as well as current hay fever.
- •8. Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency.
- •9. Laboratory values outside the reference range that are of clinical relevance.
- •10. Positive test for human immunodeficiency virus (HIV) antibodies or antigen.
- •11. Positive Hepatitis B-virus surface antigen (HBsAg) test.
- •12. Positive Anti-hepatitis C-virus antibodies (Anti-
- •13. Pregnant or nursing women.
- •14. Women of childbearing potential not using a highlyeffective method of birth control.
- •There are additional details/criteria.
研究者
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