drugset
drugset / Trial / NCT01292070

Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy

NCT01292070 ↗

Phase 0 Terminated 4 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collabTunitas Therapeutics, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD) is able to block the skin reaction to cat allergen in cat allergic subjects compared to the skin reaction to cat allergen alone. This research project is also testing the safety and tolerability of this new, experimental treatment, compared to the current treatment of cat allergen alone.

Timeline

Start
2011-03
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GFD Protein / enzyme biologic 0.001 unknown Intrathecal
Subject GFD Protein / enzyme biologic 0.01 unknown Intrathecal
Subject GFD Protein / enzyme biologic 0.1 unknown Intrathecal
Subject GFD Protein / enzyme biologic 1 unknown Intrathecal
Subject GFD Protein / enzyme biologic 10 unknown Intrathecal
Subject GFD Protein / enzyme biologic 100 unknown Intrathecal
Subject GFD Protein / enzyme biologic 1000 unknown Intrathecal
Subject GFD Protein / enzyme biologic 10000 unknown Intrathecal
Background Cat hair Unknown 0.01 unknown Intrathecal
Background Cat hair Unknown 0.1 unknown Intrathecal
Background Cat hair Unknown 1 unknown Intrathecal
Background Cat hair Unknown 10 unknown Intrathecal
Background Histamine Small molecule 1 mg/ml —

Indications

No indication recorded.