ACTRN12614000465651已完成1 期
Single centre, open label Phase 1/Phase 2 study to evaluate the safety and efficacy of Dietzia C79793-74 in moderate to severe Crohn's disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Males and females of non-childbearing potential, aged 18-75
- •- Diagnosis of moderate to severe Crohn's disease
排除标准
- •- Females of childbearing potential, pregnant or lactating females
- •- Unwilling to practice two effective methods of contraception
- •- A diagnosis of ulcerative colitis, pouchitis, indeterminate colitis
- •- Any other significant GI condition
- •- Evidence of cardiac impairment, insufficiency or disease, particularly cardiac valvular disease
- •- Severe hepatic or renal disease or impairment
- •- Known diagnosis with Type 2 diabetes mellitus
- •- History of or current infection with rheumatic fever
- •- Major immunodeficiency or immunosuppression
- •- Recently taken, actively taking or are expected to require prohibited medications
研究者
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