NCT04728711已完成2 期
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Subjects With Serious Adverse Events
研究概览
简要总结
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female, between 18 to 65 years of age (inclusive) at Screening Visit.
- •Subjects must give their signed and dated written informed consent (in English) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments.
- •Female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the Screening Visit and for at least 30 days post last dose of study drug.
- •Generally healthy subjects with mild controlled asthma for 2 years at Screening Visit according to the Global Initiative for Asthma criteria.
排除标准
- •History and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of Investigator may either put the subject at risk or influence the results during the study.
- •Positive skin prick test to other perennial allergens (i.e., mold, dog with ≥ 3 mm wheal compared to negative control). Subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season.
- •Any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator.
- •Recent hospitalization with asthma in the last 6 months or any other medical condition that the Investigator deems incompatible with participation in the trial.
研究组 & 干预措施
ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
Experimental
干预措施: ADX-629 (Drug)
Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Serious Adverse Events
时间窗: The safety assessment period was Day 1 - Day 7 for each treatment intervention.
Safety was assessed through serious adverse event collection.
次要结局
- Change From Baseline in the Asthma Control Questionnaire(The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.)
- Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes(The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.)
- Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes(The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.)
研究者
研究点 (1)
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