Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.
The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.
Study details include:
- The study duration will be approximately up to 12 to 15 weeks.
- The treatment will be administered as a single dose on Day 1.
- The number of visits will be 14.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习地点
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Florida
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Hialeah、Florida、美国、33014
- Clinical Pharmacology of Miami- Site Number : 8400001
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Male and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent.
- Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight between 50.0 and 100.0 kg, inclusive.
- BMI between 18.0 and 32.0 kg/m2 (inclusive).
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP of ≥30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to any of the study interventions, or components thereof.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Regular smoking of more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking during the study (occasional smoker can be enrolled).
- Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- If female, pregnancy (defined as positive urine pregnancy test); breast-feeding.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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 |
|---|---|
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实验性的:Treatment A
Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1
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Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
其他名称:
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实验性的:Treatment B
Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1
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Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
其他名称:
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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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Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
大体时间:From Day 1 to Day 85 (end of study)
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Cmax: Maximum concentration observed in serum
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From Day 1 to Day 85 (end of study)
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PK parameter in serum: AUClast of dupilumab
大体时间:From Day 1 to Day 85 (end of study)
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AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
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From Day 1 to Day 85 (end of study)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs
大体时间:From Day -1 to Day 85.
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From Day -1 to Day 85.
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Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
大体时间:On Day 1, Day 43 and Day 85
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On Day 1, Day 43 and Day 85
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合作者和调查者
赞助
调查人员
- 首席研究员:Angel Lamas, MD、Clinical Pharmacology of Miami (CPMI)
出版物和有用的链接
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
其他相关的 MeSH 术语
其他研究编号
- PKM20425
- U1111-1331-0702 (注册表标识符:ICTRP)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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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