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Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)

2015年2月5日 更新者：Biogen

Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects With Painful Lumbar Radiculopathy

The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

54

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

  • 荷兰
      • Leiden、荷兰
        • Center for Human Drug Research

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

Key Inclusion Criteria: Part I and Part II

  • Healthy Volunteers

Key Inclusion Criteria: Part III multiple ascending dose (MAD)

  • Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
  • Subjects must rate their pain at ≥40 mm on the 100 mm visual analog scale (VAS) of the short form McGill pain questionnaire (SF-MPQ) at the Screening and Baseline Visits.

Key Inclusion Criteria for All Subjects for Part I, Part II, Part III:

  • All male subjects and all female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. -

Key Exclusion Criteria for All Subjects for Part I, Part II, Part III:

  • History of or positive screening test for hepatitis C infection , hepatitis B infection, or positive for human immunodeficiency virus (HIV) antibody. Subjects who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive are allowed to participate if they are positive for HBsAb immunoglobulin G
  • History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
  • Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. -
  • Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
  • Previous administration of a neurotrophic factor, including BG00010.
  • Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit, or current enrollment in any other study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Single Ascending Dose (SAD): BG00010
Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart.
生物：BG00010 IV
Ascending Doses intravenous (IV) of BG00010
其他名称：
  • 神经胚素
生物：BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
其他名称：
  • 神经胚素
实验性的：SAD: Placebo
Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart.
药品：Placebo IV
Ascending Doses intravenous (IV) of Placebo
药品：Placebo SC
Ascending Doses subcutaneous (SC) of placebo
实验性的：Multiple Ascending Dose (MAD): BG00010
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
生物：BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
其他名称：
  • 神经胚素
实验性的：Multiple Ascending Dose (MAD): Placebo
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.
药品：Placebo SC
Ascending Doses subcutaneous (SC) of placebo

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
大体时间：Up to Day 75
Up to Day 75

次要结果测量

结果测量
措施说明
大体时间
Maximum observed concentration (Cmax) of BG00010
大体时间：Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Time to maximum serum concentration (Tmax) of BG00010
大体时间：Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Half life (t1/2) of BG00010
大体时间：Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
大体时间：Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Subcutaneous (SC) bioavailability
大体时间：Pre-dose and up to 24 hours post-dose
Pre-dose and up to 24 hours post-dose
Number of participants with anti-BG00010 antibodies in serum
大体时间：Up to Day 75
Up to Day 75
Pain as measured by an 11-point numeric rating scale (NRS)
大体时间：Up to Day 75
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Up to Day 75
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
大体时间：Up to Day 75
A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).
Up to Day 75

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。

赞助

Biogen

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

2013年4月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2013年4月25日

首先提交符合 QC 标准的

2013年4月25日

首次发布 (估计)

2013年4月29日

研究记录更新

最后更新发布 (估计)

2015年2月9日

上次提交的符合 QC 标准的更新

2015年2月5日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 103NS103
  • 2012-005224-15 (EudraCT编号)

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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条件

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