Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Cytos Biotechnology AG1 个研究点分布在 1 个国家目标入组 21 人开始时间: 2005年3月1日最近更新: 2008年4月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Cytos Biotechnology AG
入组人数: 21
试验地点: 1

研究概览研究设计入排标准研究组 & 干预措施研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
•Mild asthma
•Females only if non-reproductive or agree to practice an effective and accepted method of contraception

排除标准

•Relevant cardiovascular, renal, pulmonary or endocrine disease
•History of autoimmune disease
•Severe allergies
•History of active infectious disease
•Current diagnosis or history of malignancy
•Relevant neurological or psychiatric disorder
•Pregnancy or lactation
•History of alcohol abuse or other recreational drugs
•Use of an investigational drug within three month before enrolment
•Blood donation within 30 days before enrolment

研究组 & 干预措施

1

Experimental

干预措施: CYT005-AllQbG10 (Biological)

研究者

发起方

Cytos Biotechnology AG

申办方类型

Industry

研究点 (1)

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