NL-OMON41859已完成不适用
A RANDOMIZED, SINGLE DOSE, DOUBLE BLIND, PARALLEL GROUP, PHARMACOKINETIC TRIAL, COMPARING ONS-1045 (ONCOBIOLOGICS INC, USA) TO 2 ARMS OF AVASTIN® (GENENTECH, SOUTH SAN FRANCISCO, USA; ROCHE, SWITZERLAND) IN HEALTHY MALE VOLUNTEERS - Single dose study of ONS-1045 in healthy male volunteers.
Oncobiologics Inc0 个研究点目标入组 135 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Healthy Male subjects
- •- Age >=18 and <=55 years;
- •- Moderate to not smoking
- •- Body mass index 18.5- 30 kg/m2;
- •- Able and willing to give informed consent
排除标准
- •- Clinical significant laboratory abnormalities
- •- Signs and symptoms of congestive Heart Failure;
- •- Presence of non-healing wound
- •- History of stroke
- •-Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0);
- •-History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study drug administration;
研究者
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