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A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses

2021年9月28日 更新者:Janssen Research & Development, LLC

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses

The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

24

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

      • Herston、澳大利亚、4006
        • Nucleus Network, Q-Pharm Pty Ltd

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:

  • Participant must be of first to third generation Japanese descent
  • Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. 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
  • Participant must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day-1. If the results of the serum chemistry panel including 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2) and a body weight of between 50 to 90 kg inclusive
  • A female participant must have a negative pregnancy test at screening and on Day -1

Exclusion Criteria:

  • Coexisting Medical Conditions or Past Medical History: 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, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • Coexisting Medical Conditions or Past Medical History: Has known allergies, hypersensitivity, or intolerance to JNJ-77474462 or its excipients, or any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-77474462 and its excipients used in this study
  • Malignancy or Increased Potential for Malignancy: Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk and no evidence of recurrence within 5 years prior to screening
  • Concomitant or Previous Medical Therapies Received: Participant is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
  • Concomitant or Previous Medical Therapies Received: Has received over the counter medications (including vitamins/multivitamins supplements, corticosteroids, acetaminophen/paracetamol, aspirin, decongestants, antihistamines and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort, and cannabidol) within 2 weeks prior to first study intervention administration unless approved by the investigator and sponsor medical monitor
  • Infections or Predisposition to Infections: has an active acute or clinically significant chronic infection

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:顺序分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cohort 1: JNJ-77474462 (Low Dose) or Placebo
Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
JNJ-77474462 will be administered as SC injection.
其他名称:
  • 伯美克单抗
Matching placebo to JNJ-77474462 will be administered as SC injection.
实验性的:Cohort 2: JNJ-77474462 (Medium Dose) or Placebo
Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
JNJ-77474462 will be administered as SC injection.
其他名称:
  • 伯美克单抗
Matching placebo to JNJ-77474462 will be administered as SC injection.
实验性的:Cohort 3: JNJ-77474462 (High Dose) or Placebo
Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
JNJ-77474462 will be administered as SC injection.
其他名称:
  • 伯美克单抗
Matching placebo to JNJ-77474462 will be administered as SC injection.

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
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
大体时间:Up to Week 16
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.
Up to Week 16
Number of Participants with Serious Adverse Events (SAEs)
大体时间:Up to Week 16
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.
Up to Week 16
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
大体时间:Up to Week 16
An 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.
Up to Week 16
Number of Participants with Clinically Significant Changes in Vital Signs
大体时间:Up to Week 12
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
大体时间:Up to Week 12
Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.
Up to Week 12
Number of Participants with Clinically Significant Changes in Hematology
大体时间:Up to Week 12
Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count [RBS], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.
Up to Week 12
Number of Participants with Clinically Significant Changes in Chemistry
大体时间:Up to Week 12
Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
Up to Week 12
Number of Participants with Clinically Significant Changes in Urinalysis
大体时间:Up to Week 12
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
Up to Week 12

次要结果测量

结果测量
措施说明
大体时间
Maximum Observed Concentration (Cmax)
大体时间:Up to Week 12
Cmax is the maximum observed concentration.
Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
大体时间:Up to Week 12
AUC(0-infinity) is defined area under the plasma/serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
大体时间:Up to Week 12
AUC(0-last) is defined as area under the plasma/serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Up to Week 12
Time to Reach Maximum Observed Concentration (Tmax)
大体时间:Up to Week 12
Tmax is the time to reach maximum observed concentration.
Up to Week 12
Terminal Half-life (T1/2)
大体时间:Up to Week 12
T1/2 is the terminal half-life.
Up to Week 12
Apparent Total Systemic Clearance (CL/F)
大体时间:Up to Week 12
CL/F is the apparent total systemic clearance after extravascular administration.
Up to Week 12
Apparent Volume of Distribution (Vz/F)
大体时间:Up to Week 12
Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.
Up to Week 12
Number of Participants with Antibodies to JNJ-77474462
大体时间:Up to Week 12
Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported.
Up to Week 12

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10月16日

初级完成 (实际的)

2021年8月5日

研究完成 (实际的)

2021年8月5日

研究注册日期

首次提交

2020年9月9日

首先提交符合 QC 标准的

2020年9月9日

首次发布 (实际的)

2020年9月10日

研究记录更新

最后更新发布 (实际的)

2021年9月29日

上次提交的符合 QC 标准的更新

2021年9月28日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • CR108807
  • 77474462ADM1002 (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

是的

研究美国 FDA 监管的设备产品

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.

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