NCT06400719已完成1 期
An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence, nature and severity of Treatment Emergent Adverse Events
研究概览
简要总结
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Healthy male and female subjects aged between 18 and 55 years old inclusive
- •Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
- •Haematology and biochemistry tests within normal range
排除标准
- •History of relevant drug and/or food allergies
- •History of hypersensitivity to vedolizumab, AVT16 of their constituents
- •Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations
研究组 & 干预措施
AVT16
Experimental
Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab
干预措施: AVT16 (Biological)
结局指标
主要结局
Incidence, nature and severity of Treatment Emergent Adverse Events
时间窗: 18 weeks
Safety and Tolerability of AVT16
次要结局
- Maximum Plasma Concentration (Cmax) of AVT16(18 weeks)
- Frequency of anti-drug antibodies(18 weeks)
研究者
研究点 (1)
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