NL-OMON51546招募中不适用
A phase 1, randomised, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of Ent001 in healthy subjects - Ent001 IV First in Human SAD Study in adult healthy subjects
Enthera S.r.l.0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- •1. Sex: male or female; females must be of nonchildbearing potential or
- •postmenopausal.
- •2. Age: 18 to 65 years, inclusive, at screening.
- •3. Body mass index: 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening.
- •Calculated as body weight (kg) divided by height (m)2.
- •4. Weight: >=50 kg at screening.
- •5. Status: healthy subjects.
- •Further criteria apply
排除标准
- •1. Previous participation in the current study.
- •2. Employee of ICON or the Sponsor.
- •3. History of sensitivity to any of the study treatments, or components
- •thereof, or any clinically significant history of allergic conditions as judged
- •by the Investigator (including drug allergies, asthma, eczema, or anaphylactic
- •reactions, but excluding untreated, asymptomatic, seasonal allergies at the
- •time of dosing).
- •4. The subjects who have had a prior allergic reaction, including anaphylaxis,
- •to any other human, humanized, chimeric, or rodent antibodies.
- •5. Using tobacco products within 3 months prior to dosing.
- •Further criteria apply
研究者
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