A Phase I, Randomized, Open-Label, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Bioequivalence Between a High-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Needle and Syringe and a Low-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
研究概览
简要总结
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.
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
- •Healthy adults 18 to 65 years of age, inclusive
- •Body mass index (BMI) 18 to 32 kg/m^2 and body weight 50 to 100 kg, inclusive
- •Nonpregnant and nonlactating females
- •Agreement to utilize effective contraception among men and women of childbearing potential
排除标准
- •Known allergy or hypersensitivity to study drug or components
- •History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
- •Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
- •Biological therapy within 90 days prior to Day -1
- •Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
- •Receipt of blood products within 2 months prior to study entry
- •Donation or loss of blood/plasma within up to 6 months prior to study drug, depending upon volume
- •Receipt of live attenuated vaccine within 1 month prior to study drug
- •Use of tobacco- or nicotine-containing products within 14 days prior to Screening
- •Use of any prescription or nonprescription medication within 14 days prior to study drug
研究组 & 干预措施
Treatment 1: Needle and Syringe
Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe.
干预措施: Lebrikizumab (Drug)
Treatment 2: PFS-NSD
Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.
干预措施: Lebrikizumab (Drug)
结局指标
主要结局
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time to maximum concentration (Tmax) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent clearance (CL/F) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Maximum observed concentration (Cmax) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent volume of distribution (Vz/F) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination rate constant of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination half-life (t1/2) of lebrikizumab
时间窗: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
次要结局
- Incidence of adverse events(From Day -1 until study completion or premature withdrawal (up to approximately 3 months))
- Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab(From Day 1 until study completion or premature withdrawal (up to approximately 3 months))