A Study to Assess How Intravenous and Subcutaneous Administrations of Trosunilimab Move Through the Body of Healthy Adult Participants
A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Trosunilimab
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity and safety following trosunilimab SC and trosunilimab IV doses in healthy adult participants.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:ABBVIE CALL CENTER
- 电话号码:844-663-3742
- 邮箱:abbvieclinicaltrials@abbvie.com
学习地点
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Illinois
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Grayslake、Illinois、美国、60030
- 招聘中
- Acpru /Id# 286224
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, PE, vital signs, laboratory profile and a 12-lead ECG.
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 125 days after the last dose of study treatment.
Exclusion Criteria:
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History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
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Participant has any clinically significant ECG abnormalities including the following:
- Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement.
- QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.
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History of any clinically significant sensitivity or allergy to any medication or food.
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Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
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History or evidence of active tuberculosis (TB) disease or latent TB infection.
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History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 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 |
|---|---|
|
有源比较器:Arm 1: Trosunilimab IV
Participants will receive an intravenous (IV) trosunilimab dose |
Subcutaneous (SC) Injection
其他名称:
Intravenous (IV) Injection
其他名称:
|
|
有源比较器:Arm 2: Trosunilimab SC
Participants will receive subcutaneous (SC) injection doses of trosunilimab |
Subcutaneous (SC) Injection
其他名称:
Intravenous (IV) Injection
其他名称:
|
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 Serum Concentration (Cmax) of trosunilimab
大体时间:Up to 7 Days
|
Cmax of trosunilimab |
Up to 7 Days
|
|
Time to Cmax (Tmax) of trosunilimab
大体时间:Up to 7 Days
|
Tmax of trosunilimab |
Up to 7 Days
|
|
Concentration at Week 4 (Cwk4) of trosunilimab
大体时间:Week 4
|
Cwk4 of trosunilimab |
Week 4
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Area under the serum concentration-time curve from Week 0 to 4 (AUC0-4wk) of trosunilimab
大体时间:Weeks 0 to 4
|
AUC0-4wk of trosunilimab |
Weeks 0 to 4
|
|
Number of Participants Experiencing Adverse Events
大体时间:Up to 140 Days
|
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with the treatment. |
Up to 140 Days
|
合作者和调查者
赞助
调查人员
- 研究主任:ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- M26-520
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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