An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Safety and tolerability of Cat-PAD
研究概览
简要总结
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses.
详细描述
This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.
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)
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
- •A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
- •Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm.
排除标准
- •Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled).
- •A history of anaphylaxis to cat allergen.
- •Subjects with a cat specific IgE >100 kU/L.
- •Subjects with an FEV1 <80% of normal.
- •Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm.
- •Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
- •Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
- •Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria.
- •Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- •Subjects being treated with beta-blockers
结局指标
主要结局
Safety and tolerability of Cat-PAD
时间窗: 0, 7, 21 days
次要结局
- Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.(Day 21)