drugset / Trial / NCT02017626
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Phase 1/2
Completed
15 enrolled
Rigshospitalet, Denmark
Odense University Hospital · collabUniversity Hospital, Gentofte, Copenhagen · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mCyp c 1 | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.