NCT05976373已完成1 期
A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum serum concentration of functional dupilumab (Cmax)
研究概览
简要总结
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
详细描述
Duration per participant is up to 11 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants, between 18 and 65 years of age, inclusive.
- •Body weight between 70.0 and 90.0 kg, inclusive.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, 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 (more than twice a month).
- •Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -
- •Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
- •History of light-headedness or syncope during blood collection or injection of medications.
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- •If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breast-feeding.
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.
- •Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dupilumab drug product 1
Active Comparator
A single subcutaneous injection on Day 1
干预措施: Dupilumab (SAR231893) (Drug)
Dupilumab drug product 2
Experimental
A single subcutaneous injection on Day 1
干预措施: Dupilumab (SAR231893) (Drug)
结局指标
主要结局
Maximum serum concentration of functional dupilumab (Cmax)
时间窗: Pre-dose on Day 1 up to Day 57
Time to reach Cmax (Tmax)
时间窗: Pre-dose on Day 1 up to Day 57
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
时间窗: Pre-dose on Day 1 up to Day 57
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)(Day 1 up to Day 57)
- Incidence of anti-dupilumab antibodies (ADA)(Day 1 up to Day 57)
研究者
研究点 (1)
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