NCT03748758已完成1 期
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Novus Therapeutics, Inc1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月27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
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.
- •Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigator's judgement.
- •Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).
- •Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.
- •Male subjects must agree to use contraception
- •Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit.
- •Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.
排除标准
- •includes but is not limited to:
- •History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.
- •Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score <35 (for females) and <34 (for males).
- •Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.
- •History of tympanostomy tubes in one or both ears within 1 year prior to Screening.
- •Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.
- •Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.
- •Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.
- •Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.
研究组 & 干预措施
Drug: Placebo
Placebo Comparator
Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days
干预措施: Drug: Placebo (Combination Product)
Drug: OP0201 (60 mg)
Active Comparator
Cohort B-60 mg per day X 14 days
干预措施: Drug: OP0201 (Combination Product)
Drug: OP0201 (30 mg)
Active Comparator
Cohort A- 30 mg per day X 14 days
干预措施: Drug: OP0201 (Combination Product)
结局指标
主要结局
Number of Participants With of Adverse Events
时间窗: 21 Days
次要结局
- Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint(Day 1 and Day 14)
- Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint(Day 1 and Day 14)
- Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint(Day 1 and Day 14)
- Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint(Day 1 and Day 14)
研究者
研究点 (1)
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