A Phase 1, Single-center, Open-label, Randomized, Parallel Group, Single-dose Study to Compare the Pharmacokinetics of Subcutaneous Itepekimab Administered With an Autoinjector Versus Prefilled Syringe in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
研究概览
简要总结
This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP).
Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) >18.5 and ≤30 kg/m2.
Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups:
- Itepekimab administered via AI (test)
- Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (<70 kg, ≥70 to <80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm).
Study duration for each participant is up to approximately 162 days, including:
- Screening period: up to 21 days
- Institutionalization: 2 days including 1 treatment day (Day 1)
- Follow-up period: 140 days (±5 days)
- End of study (EOS): Day 141 (± 5 days)
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
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •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
Cohort 1
Itepekimab administered via AI
干预措施: Itepekimab AI (Drug)
Cohort 2
Itepekimab administered via PFS
干预措施: Itepekimab PFS (Drug)
结局指标
主要结局
Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
时间窗: Baseline up to EOS (approximately Day 141)
Maximum plasma concentration of itepekimab
Assessment of PK parameter of itepekimab: AUClast
时间窗: Baseline up to EOS (approximately Day 141)
AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Assessment of PK parameter of itepekimab: AUC
时间窗: Baseline up to EOS (approximately Day 141)
AUC: Area under the plasma concentration versus time curve extrapolated to infinity
次要结局
- Assessment of PK parameter of itepekimab: CL/F(Baseline up to EOS (approximately Day 141))
- Assessment of PK parameter of itepekimab: AUC0-28days(Baseline up to Day 28)
- Assessment of PK parameter of itepekimab: t1/2(Baseline up to EOS (approximately Day 141))
- Assessment of PK parameter of itepekimab: Vss/F(Baseline up to EOS (approximately Day 141))
- Assessment of PK parameter of itepekimab: tmax(Baseline up to EOS (approximately Day 141))
- Incidence of treatment-emergent anti-itepekimab antibodies responses(Baseline up to EOS (approximately Day 141))
- Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI)(Baseline up to EOS (approximately Day 141))