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About
The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units:
To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects.
The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.
Full description
The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.
Enrollment
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Volunteers
Inclusion criteria
Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
Case history of allergy to fish ingestion.
Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
FEV1 at least 80% of predicted values at screening.
Subject accepting to comply fully with the protocol.
For woman of child bearing potential:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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