NCT00652223CompletedPhase 1
Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 21
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
Experimental
Intervention: CYT005-AllQbG10 (Biological)
Investigators
Study Sites (1)
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