First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
2016年8月24日 更新者：Janssen Research & Development, LLC
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
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.
研究概览
研究类型
介入性
注册 (实际的)
65
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Berlin、德国、10117
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SD 0.0002 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 0.0012 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 0.007 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 0.035 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 0.175 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 0.7 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 2.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD 7.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：SD Placebo
Subjects were injected once with placebo
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Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
|
|
实验性的：MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
|
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
|
实验性的：MD Placebo
Subjects were injected biweekly four times with placebo
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Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of Adverse Events
大体时间：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.
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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.
|
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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Concentration-time Curve (AUC)
大体时间：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.
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Systemic exposure to NNC0142-0002.
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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.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Britta Væver Bysted, DVM, PhD、Novo Nordisk A/S
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年6月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2009年6月24日
首先提交符合 QC 标准的
2009年6月24日
首次发布 (估计)
2009年6月25日
研究记录更新
最后更新发布 (估计)
2016年10月3日
上次提交的符合 QC 标准的更新
2016年8月24日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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