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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02017626
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 2013
Completion date October 2014

See also
  Status Clinical Trial Phase
Completed NCT02365168 - Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish N/A
Active, not recruiting NCT05590299 - Fish Oral Immunotherapy in Hong Kong Children N/A