A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
2014年9月29日 更新者：Janssen Research & Development, LLC
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
研究概览
地位
完全的
条件
详细说明
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men.
Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion.
The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center).
During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo.
Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157.
Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level.
The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner.
An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B).
Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo.
Only Caucasian participants will be enrolled in the IV treatment group (group 4).
For each treatment group, blood and urine samples will be taken at various time points during the study.
Each participant will take part in the study for approximately 85 days.
Participant safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
40
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
-
-
California
-
Cypress、California、美国
-
-
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 55年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Exclusion Criteria:
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1A
100 mg CNTO 3157 or placebo in healthy male Japanese participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
实验性的：Group 1B
100 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
实验性的：Group 2A
300 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
实验性的：Group 2B
300 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
实验性的：Group 3A
600 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
实验性的：Group 3B
600 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
实验性的：Group 4
300 mg CNTO 3157 in healthy male Caucasian participants
|
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
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：Up to Day 57
|
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
|
Up to Day 57
|
|
Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
大体时间：Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
大体时间：Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
大体时间：Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
大体时间：Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
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。
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12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12月6日
首先提交符合 QC 标准的
2013年12月6日
首次发布 (估计)
2013年12月11日
研究记录更新
最后更新发布 (估计)
2014年9月30日
上次提交的符合 QC 标准的更新
2014年9月29日
最后验证
2014年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CR102823
- CNTO3175NAP1001 (其他标识符：Janssen Research & Development, LLC)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.