A Phase 1, Open-Label, Randomized, Parallel Group Pilot Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Needle Safety Device in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
研究概览
简要总结
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
详细描述
The drug being tested in this study is called vedolizumab SC. The study will assess the PK, and variability of a vedolizumab SC in a PFS versus an investigational device.
This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 102 participants, including 17 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (per randomization schedule) to one of the two treatment groups:
- Group A: Vedolizumab SC PFS
- Group B: Vedolizumab SC Investigational Device
All participants will receive a single dose of study drug on Day 1.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Weighs greater than (>) 50 kilogram (kg) and less than (<) 90 kg and has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m^2), inclusive, at the time of informed consent.
排除标准
- •Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antibodies or rituximab.
- •Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day
- •Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year before the Screening Visit or is unwilling to agree to abstain from alcohol for 7 days before Day -1 throughout confinement and for 48 hours before each clinic visit; and drugs throughout the study.
- •Has evidence of an active infection during the Screening Period.
- •Has received any live vaccinations within 30 days before Screening.
- •Has active or latent tuberculosis (TB) as evidenced by the following:
- •o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:
- •Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- •A TB skin test reaction greater than or equal to (>=) 5 millimeter (mm). NOTE: If participants have received Bacillus Calmette-Guerin (BCG) vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
- •Note: participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
- •Has poor peripheral venous access.
- •Is unable to attend all the study visits or comply with study procedures.
- •Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including serum pheresis), or had a transfusion of any blood product within 45 days before Day 1.
研究组 & 干预措施
Group A: Vedolizumab SC PFS
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
干预措施: Vedolizumab SC (Drug)
Group B: Vedolizumab SC Investigational Device
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
干预措施: Vedolizumab SC (Drug)
结局指标
主要结局
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
时间窗: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
时间窗: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
时间窗: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
次要结局
未报告次要终点