NCT03502954终止1 期
A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects
Affibody1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections
研究概览
简要总结
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-039 after single and multiple doses in healthy volunteers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 between 18 to 55 years of age agreeing to use highly effective methods of contraception
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, with a weight of at least 50 kg
- •Subjects in good health
- •Subjects with total immunoglobulin G (IgG) > 10 g/L at Screening
排除标准
- •Subjects who have donated blood in the 3 months prior to Screening, plasma in the 7 days prior to Screening or platelets in the 6 weeks prior to Screening
- •Subjects who have received systemic corticosteroid treatment within 3 months of first dosing
- •Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding non-active hay fever), as determined by the investigator
- •Subjects who are still participating in another clinical study or received last investigational medical product (IMP) dose in a clinical study within the following time period prior to dosing: 3 months or 5 half-lives, whichever is longer
- •History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD)
- •Positive for hepatitis A, hepatitis B, hepatitis C virus or antibodies to HIV-1 and/or HIV-2 or a positive QuantiFERON Gold Plus test at Screening
- •Subjects who have received a live vaccination within 3 months prior to Screening or plan to have a live vaccination within 3 months after the last dose of study drug
- •Subject unable or unwilling to comply with the protocol
结局指标
主要结局
Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections
时间窗: Baseline up-to 11 weeks post-dose
Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ABY-039
次要结局
未报告次要终点
研究者
研究点 (1)
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