NCT02017626

FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fish Allergy

Interventions

Type	Name	Description
BIOLOGICAL	mCyp c 1	2 patient groups with different doses of allergen.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-12-23
• Last updated: 2015-06-19

Locations

1 site across 1 country: Denmark