NCT00685711

Safety of Cat-PAD in Cat Allergic Subjects

An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Circassia Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses.

Detailed description

This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.

Conditions

• Cat Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Cat-PAD	single, escalating dose intradermal and subcutaneous injections of Cat-PAD

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-28
• Last updated: 2008-08-06

Locations

1 site across 1 country: Germany