An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- PK parameter: Cmax
研究概览
简要总结
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.
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
盲法说明
This study is open-label. Participants, investigators, and study members have access to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
- •Certified as healthy by a comprehensive clinical assessment [detailed medical history and complete physical examination including neurological exam (at screening and D1), skin, and mucous membranes].
- •Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- •Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- •History of solid organ (including corneal transplant) or stem cell transplant.
- •Any pre-planned major elective surgery known about at baseline visit that in the Investigator's opinion would impede participation in the study.
- •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.
- •Any nicotine use within 4 weeks before study inclusion. Regular smoking more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking or using nicotine for duration of the study.
- •If female, pregnancy (defined as positive beta human chorionic gonadotropin [β-HCG] blood test), breast feeding.
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Group 1
Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).
干预措施: SAR445229 (Combination Product)
Group 3
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.
干预措施: SAR445229 (Combination Product)
Group 4
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.
干预措施: SAR445229 (Combination Product)
Group 2
Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).
干预措施: SAR445229 (Combination Product)
结局指标
主要结局
PK parameter: Cmax
时间窗: From Day 1 up to End of study (approximately 24 weeks)
Maximum serum concentration observed.
Pharmacokinetic (PK) profile: AUC last
时间窗: From Day 1 up to End of study (approximately 24 weeks)
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Pharmacokinetic (PK) profile: AUC
时间窗: From Day 1 up to End of study (approximately 24 weeks)
Area under the serum concentration versus time curve extrapolated to infinity.
次要结局
- PK parameter: Tmax(From Day 1 up to End of study (approximately 24 weeks))
- PK parameter: t1/2z(From Day 1 up to End of study (approximately 24 weeks))
- PK parameter: CL/F(From Day 1 up to End of study (approximately 24 weeks))
- PK parameter: Vz/F(From Day 1 up to End of study (approximately 24 weeks))
- Pharmacokinetic (PK) profile: AUCext(From Day 1 up to End of study (approximately 24 weeks))
- Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs(Up to end of study (approximately 24 weeks))
- Percentage of participants with potentially clinically significant abnormalities(Up to end of study (approximately 24 weeks))
- Visual analog scale score for pain with subcutaneous administration(Day 1)
- Incidence of participants with ADA (antidrug antibody) against amlitelimab.(Up to end of study (approximately 24 weeks))