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Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

NCT01166061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-05-20

No results posted yet for this study

Summary

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.

ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.

Conditions

  • Allergy

Interventions

BIOLOGICAL

Placebo

Solution resembling active solution but without peptides

BIOLOGICAL

ToleroMune Grass

1 x4 administrations 4 weeks apart

Sponsors & Collaborators

  • Adiga Life Sciences, Inc.

    collaborator INDUSTRY

  • Circassia Limited

    lead INDUSTRY

Principal Investigators

  • Jacques Hebert, MD · Centre de recherche appliquée en allergie de Quebec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166061 on ClinicalTrials.gov