A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 14
- 主要终点
- Primary Outcome - Safety and Tolerability
研究概览
简要总结
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.
详细描述
The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.
The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There will be a placebo match and blinded randomization.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent.
- •Male or female 18-70 years of age.
- •Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
- •CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
- •Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.
排除标准
- •History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia.
- •History of surgery that led to hyposmia.
- •Concomitant Medical Conditions
- •Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
- •Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
- •Any active malignancy.
- •Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data.
- •History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator.
- •History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps.
- •Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS.
- •Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline.
- •Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up.
- •Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data.
- •General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating.
- •Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.
研究组 & 干预措施
CYR-064 dose 1
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
干预措施: CYR-064 (Combination Product)
CYR-064 dose 2
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
干预措施: CYR-064 (Combination Product)
Placebo
Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.
干预措施: CYR-064 (Combination Product)
结局指标
主要结局
Primary Outcome - Safety and Tolerability
时间窗: Approximately 32 weeks
The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.
次要结局
- Secondary Outcome-Mean Change in NRS-11 Taste-PRO(Approximately 24 weeks)
- Secondary Outcome-improvement on NRS-11 Smell-PRO(Approximately 24 weeks)
- Secondary Outcome-improvement on NRS-11 Taste-PRO(Approximately 24 weeks)
- Secondary Outcome-Mean Change in NRS-11 Smell-PRO(Approximately 24 weeks)
- Change in Visual Rating Scale (VRS) scores(Approximately 24 weeks)