NCT01611688已完成1 期
First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
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
- •Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
- •Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
排除标准
- •Subjects with chronic inflammatory autoimmune disease other than RA
- •History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
- •Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
- •Clinically significant cardiac or cardiovascular disease
- •Past or current malignancy
- •Latent or active tuberculosis (TB) as documented by: A positive QuantiFeron® test (test can be performed up to 2 months prior to dosing). One retest is allowed in case of inconclusive results.- A history of active TB within the last 3 years even, if treated effectively. - A history of active TB more than 3 years ago, if there is no documentation that the prior anti-TB treatment was appropriate in duration and type
研究组 & 干预措施
Active
Experimental
干预措施: NNC0215-0384 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 10 weeks after trial product administration
次要结局
- Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils(Up to 10 weeks after drug administration)
- Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)(Up to 10 weeks after drug administration)
- I.v. administration: AUC, Area under the curve(Up to 10 weeks after drug administration)
- I.v. administration: terminal half-life (t½)(Up to 10 weeks after drug administration)
- S.c. administration: AUC, Area under the curve(Up to 10 weeks after drug administration)
- S.c. administration: terminal half-life (t½)(Up to 10 weeks after drug administration)
研究者
研究点 (1)
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