NCT01370902已完成1 期
A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
- •Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
- •Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
- •Males must be willing to use highly effective contraception
- •Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
排除标准
- 未提供
研究组 & 干预措施
Single-dose (SD) trial part (i.v.)
Experimental
干预措施: placebo (Drug)
Single-dose (SD) trial part (i.v.)
Experimental
干预措施: NNC 0141-0000-0100 (Drug)
Single-dose (SD) trial part (s.c.)
Experimental
干预措施: NNC 0141-0000-0100 (Drug)
Single-dose (SD) trial part (s.c.)
Experimental
干预措施: placebo (Drug)
Multiple-dose (MD) trial part (s.c.)
Experimental
干预措施: NNC 0141-0000-0100 (Drug)
Multiple-dose (MD) trial part (s.c.)
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: from trial product administration to week 12
次要结局
- Antibodies against NNC141-0100(from trial product administration until final visit (week 12 or longer if applicable))
- Terminal half-life (t½) - MD trial part(from trial product administration until final visit (week 12 or longer if applicable))
- Area under the serum concentration-time curve - SD trial part(from trial product administration until final visit (week 12 or longer if applicable))
- Terminal half-life (t½) - SD trial part(from trial product administration until final visit (week 12 or longer if applicable))
研究者
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