A Phase 1, Randomized, Open-label, Parallel-design Study to Compare Single-dose Pharmacokinetics of Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.
详细描述
This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug is assigned by chance), parallel (a clinical trial comparing the response in two or more groups of participants receiving different treatments), open-label (all people know the identity of the intervention) single-dose, inpatient/outpatient study in healthy participants. The study consists of following periods: Screening (within 28 days before study drug administration), inpatient period (Day 1 to 4) and outpatient period (up to Day 141). Eligible participants will be randomly assigned in a 1:1 ratio to either 1 of 2 treatment groups (that is, Ustekinumab 90 mg/mL or Ustekinumab 5 mg/mL) and will receive treatment on Day 1. The PK comparability of 2 different formulations of ustekinumab, diluted in saline, will be evaluated primarily. Participants' safety will be monitored throughout the study.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive and a body mass index (BMI) of 18.5 kilogram per square meter (kg/m^2) to 29.0 kg/m^2, inclusive
- •If a woman, she must be incapable of pregnancy or using a highly effective method of birth control
- •A woman must have a negative serum pregnancy test
- •A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
- •Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Are nonsmokers or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
排除标准
- •Participant currently has or has a history of any clinically significant medical illness or medical disorders including malignancy
- •Participant has previously received ustekinumab
- •Participant has a known or suspected intolerance or hypersensitivity to any biologic medication including ustekinumab
- •Participant has received an investigational drug within a specified period prior to the planned first dose of study drug or is currently enrolled in an investigational study
研究组 & 干预措施
Ustekinumab 90 mg/mL
干预措施: Ustekinumab (Drug)
Ustekinumab 5 mg/mL
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])
时间窗: Day 0 through Day 113
The AUC(0-inf) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 0 through Day 113
The Cmax is the maximum observed plasma concentration of study drug.
次要结局
- Volume of distribution (Vz)(Day 0 through Day 113)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Baseline up to Day 141)
- Total systemic clearance (CL)(Day 0 through Day 113)
- Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])(Day 0 through Day 113)
- Terminal half-life (T1/2)(Day 0 through Day 113)
- Number of participants with antibodies to ustekinumab(Baseline, Days 57 and 113)