Loading clinical trials...

Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

NCT01111279•BioTech Tools S.A.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has given written informed consent
•Age between 18 and 50 years
•The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
•Male or non pregnant, non-lactating female
•Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
•Allergy diagnosis:
•* A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during the two previous years
•* A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
•* Specific IgE against grass pollen (RAST class 2 or IgE \> 0.7 kU/l)
•* Asymptomatic to perennial inhalant allergens even if shown to be hypersensitive in a skin prick test.

Exclusion Criteria

•Subjects with current or past immunotherapy (any time in the past)
•A history of hypersensitivity to the excipients
•Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
•Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
•Subjects with a history of hepatic or renal disease
•Subjects symptomatic to perennial inhalant allergens
•Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
•Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease)
•Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
•Subjects requiring beta-blockers medication
+15 more criteria

Locations (1)

UZ Leuven, Gasthuisberg

Leuven, Belgium

Key Dates

Start Date

March 1, 2010

Primary Completion Date

September 1, 2010

Completion Date

November 1, 2010

Last Updated

March 1, 2011

Enrollment

ESTIMATED participants

Conditions

Seasonal Allergic Rhinoconjunctivitis

Interventions

gpASIT+TM

BIOLOGICAL

gpAST+TM/adjuvant

BIOLOGICAL

Placebo solution

BIOLOGICAL