Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis

NCT00813046 | Completed Phase 1 DMC

• 2 other identifiers: BTT-gpASIT002EudraCT 2008-006368-12
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.

Conditions

Seasonal Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction.

  10 days

Secondary Outcomes (1)

• vital signs clinical laboratory evaluations adverse events general physical status

  10 days

Study Arms (1)

gpASIT+TM

EXPERIMENTAL

Biological: gpASIT+TM

Interventions

gpASIT+TM BIOLOGICAL

oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days

gpASIT+TM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 females
• A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
• A positive skin prick test to grass-pollen mixture
• Specific IgE against grass pollen (RAST class 2 or IgE \> 0.7 kU/l)
• Asymptomatic to perennial inhalant allergens

You may not qualify if:

• Subjects with current or past immunotherapy for SAR
• Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
• Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
• Subjects with a history of food allergy and consecutive anaphylaxis
• Subjects with a history of hepatic or renal disease
• Subject with malignant disease, autoimmune disease
• Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD).
• Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal \[defined as a minimum of one year since the last menstrual period\])
• 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 with clinically relevant abnormal QTc intervals of the ECG : QTc \> 450 ms for man and \> 470 ms for women
• Subjects requiring beta-blockers medication
• Chronic use of concomitant medications that would affect assessment of the effectiveness of the study medication (e.g. tricyclic antidepressants)
• Subject with febrile illness (\> 37.5°C, oral)
• A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
• The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry

Sponsors & Collaborators

• BioTech Tools S.A.: lead

Study Sites (1)

Hospital University Ghent

Ghent, 9000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

BE (1)