A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
- •Aged between 18 and 75 years (both inclusive)
- •Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
- •Use of highly effective contraception during the trial (both males and females)
排除标准
- •A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
- •An active or latent tuberculosis
- •Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
- •A known significant cardio-vascular disease
- •Vaccination against live virus or bacteria within 4 weeks prior to randomization
- •The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
- •A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
- •Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
研究组 & 干预措施
SD 0.0002 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 0.0012 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 0.007 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 0.035 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 0.175 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 0.7 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 2.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg
干预措施: NNC0142-0002 (Drug)
SD 7.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg
干预措施: NNC0142-0002 (Drug)
SD Placebo
Subjects were injected once with placebo
干预措施: placebo (Drug)
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
干预措施: NNC0142-0002 (Drug)
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
干预措施: NNC0142-0002 (Drug)
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
干预措施: NNC0142-0002 (Drug)
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
干预措施: NNC0142-0002 (Drug)
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
干预措施: NNC0142-0002 (Drug)
MD Placebo
Subjects were injected biweekly four times with placebo
干预措施: placebo (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
次要结局
- Area Under the Concentration-time Curve (AUC)(Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.)