NCT04266028已完成1 期
A Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Desentum Oy
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
详细描述
The study will be carried out in a single study site located in Finland.
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)
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
- •Males or females, aged 18 to 65 years
- •Good general health
- •A documented clinical history of 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 allergy seasons.
- •Bet v 1 specific serum IgE ≥ 0.7 kU/L
- •Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm
- •Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m
排除标准
- •History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
- •Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening.
- •History of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
- •Forced Expiratory Volume in one second (FEV1) < 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit.
- •History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the 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 until 28 days following the last dose.
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
次要结局
- Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo(From the first dose until 28 days following the last dose.)
- Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo(From the first dose until 28 days following the last dose.)
- Subjects Reaching the Pre-defined DM-101 Dose(From the first dose until 28 days following the last dose.)
研究者
研究点 (1)
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