Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy
|Cat Allergy||Biological: Intradermal Human Fcγ1-Fel d1 fusion protein Biological: Positive Control - standardized cat hair allergenic extract (CAT) Biological: Positive Control - Histamine Prick Biological: Negative Control - Intradermal Diluent||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Dose-Escalating Phase 0 Study to Evaluate the Safety and Local Cutaneous Reactivity of Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD) in Cat-allergic Healthy Volunteers|
- Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema [ Time Frame: up to 3 hours after the last injection of GFD ]Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.
|Study Start Date:||March 2011|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Control-Experimental arm
Each subject will serve as their own control with the left arm receiving the control protein (Histamine prick, intradermal diluent and intradermal CAT) and right arm receiving the experimental protein (GFD).
Biological: Intradermal Human Fcγ1-Fel d1 fusion protein
Biological: Positive Control - standardized cat hair allergenic extract (CAT)
Part A: 7 sequential 10-fold dose increments from 0.001 BAU/mL to 1,000 BAU/mL; An 8th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm.
Part B: 5 sequential 10-fold dose increments from 0.1 BAU/mL to 1,000 BAU/mL; An 6th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm.
4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mLBiological: Positive Control - Histamine Prick
Other Name: Histatrol GLYBiological: Negative Control - Intradermal Diluent
Saline, Albumin with Phenol (HSA) sterile diluent
Researchers are conducting a research study of a new protein developed to treat sensitivity to cat allergens. Cat allergy in humans is an allergic reaction to one or more of the five known allergens produced by cats. The most common of these is the protein Fel d 1.
This study will test Intradermal Human Fcγ1-Fel d1 fusion protein (GFD), a new protein that, based on animal data, has been developed to block the allergic effects of cat. If this drug works the way they think it does, it may become a treatment for cat allergy that is faster than the currently available treatments and with fewer side effects. This protein contains the molecule from the cat, that causes the allergic reaction, attached to a section of a particular antibody (protein involved in immunity) called Fcγ1 that acts like a break. The fusion of the two proteins is predicted to interrupt the flow of cellular reactions which lead to the allergic response.
This will be the first time GFD is administered to humans. The study will be conducted in two parts. The subjects in part A will be administered intradermal standardized cat hair allergenic extract (CAT) and GFD sequentially in 10-fold increasing doses every 20 minutes. If Part A demonstrates the safety of GFD,subject in part B will begin by following the same treatment as part A followed by a rechallenge of the sites with CAT at 4 hours after the first dose of GFD. Each subject will be evaluated 3 times (screening, dosing, and telephone follow-up 2 days post dosing) and will return on Day 28 for blood draw.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292070
|Alfred Hospital and Monash University|
|Melbourne, Victoria, Australia, 3004|
|Study Chair:||Andy Saxon, MD, PhD||University of California, Los Angeles (UCLA)|