NCT03013881已完成1 期
Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
United BioPharma1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年3月5日最近更新:
适应症
干预措施
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
- 1
- 主要终点
- Adverse event incidence
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
详细描述
This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Total body weight ≧50 kg (110 lbs)
- •No clinically relevant abnormalities
- •To agree on using birth control barrier (eg. male condom) during the entire study period.
- •Signing the written informed consent form
排除标准
- •Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational
- •A history of drug abuse or heavy drinking.
- •Blood donation over 250 mL within 90 days prior to the screening
- •Not in the condition to participate in this study considered by investigator(s)
研究组 & 干预措施
UB-921 6 mg/kg (Sub-study)
Experimental
Intravenous infusion
干预措施: UB-921 (Biological)
UB-921 6 mg/kg (Main-study)
Experimental
Intravenous infusion
干预措施: UB-921 (Biological)
UB-921 2 mg/kg (Main-study)
Experimental
Intravenous infusion
干预措施: UB-921 (Biological)
UB-921 8 mg/kg (Main-study)
Experimental
Intravenous infusion
干预措施: UB-921 (Biological)
Herceptin 6 mg/kg (Sub-study)
Active Comparator
Intravenous infusion
干预措施: Herceptin (Biological)
结局指标
主要结局
Adverse event incidence
时间窗: 63 days
from the baseline to the end of study visit
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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