NCT03239379已完成1 期
A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
Bioniz Therapeutics1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence, severity and relationship of treatment-emergent adverse events
研究概览
简要总结
This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Single-blind, placebo-controlled
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
- •Non-smoker.
- •Weight ≤100 kg (due to drug supply limitations).
- •Body Mass Index (BMI) ≥19 and <35 kg/m
- •Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, respiratory rate), and ECG.
- •Willing and able to consent and participate in the study.
- •Subject agrees not to receive any other investigational product or therapy while participating in this study.
- •Agrees to use adequate effective birth control methods prior to, during and for 30 days after the study.
排除标准
- •Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
- •History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- •History of or currently active primary or secondary immunodeficiency.
- •Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening.
- •Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
- •Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- •Subject has received an immunization within 14 days prior to study drug administration.
- •History of alcohol or drug abuse within 1 year prior to screening.
- •Subject requires the ongoing use of prescription medication other than oral contraceptives.
研究组 & 干预措施
Placebo
Placebo Comparator
Normal saline
干预措施: Placebo (Drug)
BNZ132-1-40
Experimental
PEGylated BNZ-1 for Injection
干预措施: BNZ132-1-40 (Drug)
结局指标
主要结局
Incidence, severity and relationship of treatment-emergent adverse events
时间窗: 8 weeks
general safety evaluation by principal investigator
次要结局
- single-dose and steady state AUC0-t(8 weeks)
- single-dose and steady state Cmax(8 weeks)
- Change from baseline for Natural Killer Cells(8 weeks)
- Change from baseline for Regulatory T-cells (Tregs)(8 weeks)
- Change from baseline for CD8+ central memory T-cells (Tcm)(8 weeks)
- Steady-state Elimination half-life (t1/2)(8 weeks)
研究者
研究点 (1)
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