A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Desentum Oy
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.
详细描述
The study will be carried out in a single study site located in Canada
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator)
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
- •Either sex or any race, aged 18 to 65 years
- •Good general health
- •A documented clinical history of moderate to severe birch pollen induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over at least 2 previous birch pollen seasons
- •Birch pollen specific IgE ≥ 0.7 kU/L
- •Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm
- •Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2
排除标准
- •History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial
- •Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening
- •Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season
- •History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past
- •A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value
- •History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: From the first dose to until 14-28 days from the last dose
Occurrence of treatment emergent adverse events
Adverse Events of Special Interest
时间窗: From the first dose to until 14-28 days from the last dose
Occurrence of local injection site reactions and systemic allergic reactions
次要结局
- Subjects Reaching the Maximum Intended Dose(Through the treatment period, an average of 10 weeks)