Cat Allergy Clinical Trial
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
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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