A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 3
- 主要终点
- To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio
研究概览
简要总结
The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.
详细描述
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.
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
- Double (Participant, Investigator)
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
- •Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
- •Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive).
- •Participant must be 18 to 55 years old inclusive, at the time of signing the ICF.
排除标准
- •Participant has a history of relevant drug and/or food allergies.
- •Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents.
- •Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders).
研究组 & 干预措施
AVT80
Single subcutaneous administration of AVT80
干预措施: AVT80 (Biological)
Geographical region 1 Entyvio
Single subcutaneous administration of Geographical region 1 Entyvio
干预措施: Geographical region 1 Entyvio (Biological)
Geographical region 2 Entyvio
Single subcutaneous administration of Geographical region 2 Entyvio
干预措施: Geographical region 2 Entyvio (Biological)
结局指标
主要结局
To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio
时间窗: Day Zero to Day 126
PK endpoint of AUC0-inf.
次要结局
未报告次要终点