A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
2021年8月25日 更新者:Janssen Research & Development, LLC
An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.
研究概览
研究类型
介入性
注册 (实际的)
140
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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Berlin、德国、13353
- CRS Clinical Research Services Berlin GmbH
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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 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Be healthy on the basis of physical examination, medical history, vital signs and electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- Must be a non-user or light user of tobacco products (not smoke more than 10 cigarettes or equivalent a day for at least 6 months prior to screening), including all nicotine use, example, cigarettes (including e-cigarettes or the equivalent of e-cigarettes), cigars, chewing tobacco, patch, gum
- Participant is considered eligible according to the following tuberculosis (TB) screening criteria: (a) have no history of latent or active TB before screening; (b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; (c) have had no recent close contact with a person with active TB; (d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention
Exclusion Criteria:
- History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Has a current chronic infection, prior history of recurrent infection, or an active infection
- Received any systemic immunosuppressant agent (other than a short course of corticosteroids for minor inflammatory conditions) within 6 months before and during screening and administration of study intervention
- Has a positive urine drug or alcohol screen during screening or at admission (Day -1)
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:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Group 1: Guselkumab PFS-U
Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.
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Guselkumab will be administered as IV solution derived from FVP or PFS-U.
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实验性的:Group 2: Guselkumab FVP
Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.
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Guselkumab will be administered as IV solution derived from FVP or PFS-U.
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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 |
---|---|---|
Maximum Observed Serum Concentration (Cmax)
大体时间:Up to Day 85
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Cmax is defined as maximum observed serum concentration.
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Up to Day 85
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Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity])
大体时间:Up to Day 85
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AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase.
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Up to Day 85
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
大体时间:Up to Day 85
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to Day 85
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Percentage of Participants with Serious Adverse Events (SAEs)
大体时间:Up to Day 85
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A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Up to Day 85
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Percentage of Participants with Clinically Significant Changes in Vital Signs
大体时间:Up to Day 85
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Percentage of participants with clinically significant changes in vital signs (including temperature (oral), pulse/heart rate, respiratory rate, and blood pressure) will be reported.
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Up to Day 85
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Percentage of Participants with Clinically Significant Changes in Physical Examinations
大体时间:Up to Day 85
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Percentage of participants with clinically significant changes in physical examinations (including general appearance, respiratory, cardiovascular, assessment of the skin at or around the intravenous [IV] administration area) will be reported.
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Up to Day 85
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Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests
大体时间:Up to Day 85
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Percentage of participants with clinically significant changes in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
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Up to Day 85
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Percentage of Participants with Antibodies to Guselkumab
大体时间:Up to Day 85
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Percentage of participants with antibodies to guselkumab will be reported.
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Up to Day 85
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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。
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 (实际的)
2020年11月30日
初级完成 (实际的)
2021年7月20日
研究完成 (实际的)
2021年7月20日
研究注册日期
首次提交
2020年11月3日
首先提交符合 QC 标准的
2020年11月3日
首次发布 (实际的)
2020年11月5日
研究记录更新
最后更新发布 (实际的)
2021年8月30日
上次提交的符合 QC 标准的更新
2021年8月25日
最后验证
2021年8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
- CR108895
- CNTO1959EDI1001 (其他标识符:Janssen Research & Development, LLC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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.
Guselkumab的临床试验
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Janssen Research & Development, LLC完全的
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Janssen Research & Development, LLC终止
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