NCT03046459已完成1 期
A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40
Bioniz Therapeutics2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- The proportion of subjects with related, treatment-emergent adverse events
研究概览
简要总结
This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.
详细描述
This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and non-pregnant, non-lactating females
- •no ongoing clinically significant medical condition
- •willing and able to provide informed consent
- •no use of Rx or OTC medications, other than oral contraceptives
排除标准
- •Recent systemic infections
- •Clinically-significant abnormal clinical labs, ECG or physical examination
- •Immunization 30 days prior to study
结局指标
主要结局
The proportion of subjects with related, treatment-emergent adverse events
时间窗: 30 days
次要结局
- PK: Exposure as determined by maximum plasma concentration (Cmax)(1 Day)
- PK: Exposure as determined by area under the concentration-time curve (AUC)(30 days)
- PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis(30 days)
研究者
研究点 (2)
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