NL-OMON23997暂停不适用
Randomized, double blind, placebo- and active comparator controlled 3-way cross over study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous administration of ENX-201
EnhanX Biopharm Inc.0 个研究点目标入组 12 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
- 暂停
- 发起方
- 入组人数
- 12
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
入选标准
- •Healthy male and female volunteers, who are able to understand and follow study instructions, age between 18 and 60 years (inclusive), and weight within normal range (body mass index within 18 to 29.9 kg/m2) and at least 50 kg.
排除标准
- •Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day); More than moderate alcohol consumption or a history of alcohol abuse; drug abuse; consumption of furanocoumarin containing citrus fruits within 7 days of first dosing; Consumption of quinine-containing drinks within 7 days of first dosing; Use of any medications other than highly effective anti-conceptive medicines, vitamins, mineral, herbal and dietary supplements within 21 days of first dosing.; Vaccinations within 3 months prior to screening; Demonstrating any active physical or psychiatric disease, acute or chronic; Any suicidal actuations (Columbia suicide severity rating-scale, CSSR-S); Any history of drug hypersensitivity, asthma, urticaria, multiple or severe allergies or drug allergies as well as current hay fever; Any history of hypersensitivity to the IMPs or components thereof; Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (esp. history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency; Infection or inflammation within 1 month prior to first dosing; Clinically significant laboratory values outside the reference range; Clinically significant increased value of glycosylated hemoglobin; Positive test for HIV antibodies or Hepatitis B-virus or Hepatitis C-virus; Positive Mendel–Mantoux test; Blood donation of 500 mL or more within 3 months prior to screening; Having received any blood transfusions or blood components within 2 months prior to screening; Participation in the treatment phase of a clinical trial within 3 months prior to screening or blocked by the follow-up period of a previous clinical trial before signing informed consent to this trial; Women of childbearing potential not using a highly effective method of birth control; Women who are pregnant or breast-feeding; Male subjects who are not surgically sterile have to use contraception during sexual intercourse with women of childbearing potential; Subject is in custody; Criteria which in the opinion of the investigator preclude participation; Previous assignment to treatment (e.g. randomization) during this study; Close affiliation with the investigator; Unable/unwilling to comply with study restrictions
研究者
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