A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.
The participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.
Participants will be in the study for approximately up to 24 weeks.
研究概览
地位
条件
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:Sabine Coppieters, MD
- 电话号码:857-350-4834
- 邮箱:clinicaltrials@argenx.com
学习地点
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Montreal、加拿大、H3P 3P1
- 招聘中
- Altasciences
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接触:
- Gaetano Morelli, MD
- 电话号码:857-350-4834
- 邮箱:clinicaltrials@argenx.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg/m2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight <60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg/m2, inclusive, at screening and on day -1 for part 2.
- Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
Exclusion Criteria:
- Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and/or food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.
- Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Part 1 - Adimanebart IV
Participants randomized to receive adimanebart IV
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Intravenous infusion of adimanebart IV
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实验性的:Part 1 - Adimanebart SC (formulation A)
Participants randomized to receive adimanebart SC
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Subcutaneous administration of Adminanebart SC
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实验性的:Part 2 - Adimanebart SC (formulation A) in lower body weights
Participants with body weight < 60 kg will receive adimanebart SC
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Subcutaneous administration of Adminanebart SC
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实验性的:Part 2 - Adimanebart SC (formulation A) in higher body weights
Participants with body weight between 100 and 130 kg will receive adimanebart SC
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Subcutaneous administration of Adminanebart SC
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实验性的:Part 3 - Adimanebart SC (formulation B)
Participants randomized to receive adimanebart SC formulation B
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Subcutaneous administration of Adminanebart SC
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实验性的:Part 3 - Adimanebart SC (formulation C)
Participants randomized to receive adimanebart SC formulation C
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Subcutaneous administration of Adminanebart SC
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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 |
|---|---|---|
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AUC0-inf
大体时间:Up to 20 weeks
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AUC0-inf = area under the concentration-time curve from time 0 to infinity
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Up to 20 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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adimanebart SC PK parameter: Cmax
大体时间:Up to 20 weeks
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Cmax = maximum observed concentration
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Up to 20 weeks
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Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation
大体时间:Up to 20 weeks
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AE = adverse event ; SAE = serious adverse event
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Up to 20 weeks
|
合作者和调查者
赞助
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
其他研究编号
- ARGX-119-900-XIND-1002
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
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