NL-OMON46131已完成不适用
Randomized, double blind, placebo- and active comparator- controlled 3-way crossover study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ENX-201 - Safety, PK and PD study with 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:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Fitzpatrick skin type 1-4 (inclusive)
- •General good health
- •Subjects aged 18 to 60 years (inclusive)
排除标准
- •- More than moderate smoker (>10 cigarettes or equivalent tobacco products/day).
- •- More than moderate alcohol consumption. Defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of
- •more than 2 units (females).
- •- Use of any medications (prescription or over the counter) other than highly effective anti-conceptive medicines, vitamins, mineral, herbal and dietary supplements within 21 days of first dosing.
- •- Any history of drug hypersensitivity, asthma, urticaria, multiple or severe allergies or drug allergies as well as current hay fever. Note: nonactive hay fever is acceptable.
- •- Positive test for human immunodeficiency virus antibodies, hepatitis B-virus surface antigen, Anti-hepatitis C-virus antibodies.
- •- Positive test result for tuberculosis testing.
- •- 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
研究者
相似试验
已完成
3 期
Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitisIncomplete microscopic colitisinflammation large intestine10017969NL-OMON45182Dr. Falk Pharma GmbH1
已完成
3 期
A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.eczema1003871610040785atopic dermatitisNL-OMON39465Danone Research - Centre for Specialised Nutrition144
已完成
2 期
A randomized, placebo-controlled, double-blind, parallel-group, multi-center, exploratory dose-response study to assess the efficacy and safety of different oral doses of BAY1128688 in women with symptomatic endometriosis over a 12-week treatment periodpain during intercourse ('dyspareunia') and non-cyclic pelvic pain.Well-accepted lay language synomyms for endometriosis are not known to us. Endometriosis describes the presence of endometrium elsewhere than in the lining of the uterus. It is associated with pelvic pain during menstruation called 'dysmenorrhea'10038612NL-OMON46660Bayer5
已完成
不适用
A double-blind, placebo-controlled, randomized clinical pharmacology study to evaluate the prevention effect and the recovery-promoting effect of a single subcutaneous administration of GYM329 on disuse muscle atrophy in healthy male volunteers.Muscular Atrophy10028302NL-OMON54969Chugai Pharmaceutical Co., Ltd.48
已完成
3 期
A double-blind, randomized-withdrawal, placebo-controlled study to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care for the treatment of refractory antibody mediated rejection in adult renal transplant recipientsantibody-mediated kidney transplant rejection'kidney graft rejection after renal transplant' and 'kidney not working properly after kidney transplant and not responsive to standard therapy'10027665NL-OMON50633CSL Behring LLC4