NL-OMON32271已完成不适用
A phase 1, first human exposure, single dose, double-blind, randomized, placebo controlled trial to assess the safety, tolerability, pharmacokinetics and pharmaco-dynamics after oral administration of Org 48775-0 in healthy male volunteers in fasted and fed state, in female healthy volunteers, and in rheumatoid arthritis patients with active disease while on methotrexate treatment. - Phase 1 Org 48775-0
Organon Nederland BV0 个研究点目标入组 50 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
- 已完成
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Male volunteers: healthy
- •Female volunteers: healthy and post-menopausal
- •Patients: active disease and treatment with MTX
排除标准
- •Volunteers: clinically significant abnormalities (females: possible fertile)
- •Patients: clinically significant abnormalities (females: possible fertile) and recent treatment with anti-TNF therapy
研究者
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