ISRCTN09512688已完成不适用
A First-in-Human Phase I, double-blind, randomised, placebo-controlled study in healthy male volunteers to investigate the safety, tolerability and pharmacokinetics of recombinant human soluble Fc gamma receptor IIb, sFc?RIIb (SM101) administered intravenously as single ascending doses
SuppreMol GmbH (Germany)0 个研究点目标入组 42 人开始时间: 2009年9月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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
- 性别
- Male
入选标准
- •1. Male, Caucasian subjects aged between 18-40 years (inclusive)
- •2. Healthy subjects as determined by medical history, physical examination including vital signs, electrocardiography (ECG) and clinical laboratory testing
- •3. Body weight between 70-90 kg and body mass index (BMI) between 19 and 28 kg/m^2, extremes included
- •4. ECG recording based on a 12-lead ECG which is normal (PR <210 ms, QRS <110 ms, QTC 380-430 ms) or contains only slight deviations deemed to be of no clinical relevance by the investigator
- •5. Normal vital signs (after 5 minutes resting), blood pressure values (systolic >=100 and <=140 mmHg, diastolic >=50 and <=90 mmHg), heart rate between 40 and 90 beats per minute (bpm), body temperature <37.5°C
- •6. Subjects who are able and willing to give written informed consent
- •7. Normal white blood cell count, C-reactive protein (CRP) and interleukin-6 (IL-6) at screening and on the day before treatment start
- •8. Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following dosing
排除标准
- •1. In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases
- •2. Infection or known inflammatory process
- •3. Subjects with known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency
- •4. Clinical significant allergic disease
- •5. Subjects with known serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies
- •6. 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 the last dose of study drug
- •7. Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents
- •8. The use of any concomitant prescription or non-prescription medication within 14 days prior to the first administration of study medication until follow-up; or treatment with medication that may affect immune function (e.g. immunoglobulins, corticosteroids) within 6 months before dosing
- •9. Donation of blood (>400 ml) or blood products within the last 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to study start
- •10. Definite or suspected personal history of adverse reactions or hypersensitivity to drugs especially to the trial compounds (E. coli-derived proteins, Tween, mannitol) or to compounds with a similar structure
- •11. Subjects who drink more than 5 cups or glasses of coffee, tea and/or cola per day
- •12. Subjects with a presence or history of drug and/or alcohol abuse or an average daily intake of more than 20 g alcohol per day
- •13. Subjects with a positive test for alcohol or drugs at screening and on the day before treatment start
- •14. Smokers of >5 cigarettes/day or equivalent
- •15. Subjects who are unlikely to be compliant and attend scheduled clinic visits as required
- •16. Participation in this study on a previous dose level
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