ACTRN12624000635561尚未招募1 期
A randomised, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intranasal INNA-051 doses delivered via dry powder spray in adult volunteers aged 60 years or older
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •Males and females 60 years of age or older
- •Without clinically defined unstable disease, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- •- Body weight 50 kg or above and body mass index (BMI) 18 to 34.9 kg/m2 (inclusive).
- •- Forced expiratory volume in one second (FEV1) at least 80% of the predicted value at Screening.
排除标准
- •- Any significant disease or disorder which may put the subject at risk because of participation in the study, influence the results of the study or the participant’s ability to participate in the study.
- •- History or evidence of tachyarrhythmias, heart block, or ischemic changes.
- •- Clinically significant abnormal laboratory assessments
- •- Chronic tobacco use, chronic cannabis smoking, or chronic vaping.
- •- Nasal conditions likely to affect the outcome of the study, for example nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
- •- Active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis
- •- Upper respiratory tract infection or nasal symptoms
研究者
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