NCT03828149已完成1 期
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo
Novus Therapeutics, Inc2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Safety (Evaluation of Adverse Events)
研究概览
简要总结
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
详细描述
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •includes but is not limited to:
- •Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
- •No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
- •Negative urine pregnancy test at screening and baseline for females of childbearing potential
- •Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
- •Physiologic tympanogram type A (normal) or type C at screening visit
排除标准
- •includes but is not limited to:
- •Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
- •Positive urine drug screen at screening visit
- •Upper respiratory tract infection currently or within 6 weeks prior to screening visit
- •Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
- •Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
- •Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
- •Clinically significant findings on ear nose and throat exam
- •Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
- •Current diagnosis of sleep apnea
- •Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
- •Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
结局指标
主要结局
Safety (Evaluation of Adverse Events)
时间窗: Days 1-9
All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
次要结局
未报告次要终点
研究者
研究点 (2)
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