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

NCT01111279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-03-01

No results posted yet for this study

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.

Conditions

  • Seasonal Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

gpASIT+TM

1 subcutaneous injection every 7 days, during 29 days.

BIOLOGICAL

gpAST+TM/adjuvant

1 subcutaneous injection every 7 days, during 29 days

BIOLOGICAL

Placebo solution

1 subcutaneous injection every 7 days, during 29 days

Sponsors & Collaborators

  • BioTech Tools S.A.

    lead INDUSTRY

Principal Investigators

  • Jan Ceuppens, Professor · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-11-30

Countries

  • Belgium

Study Locations

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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 NCT01111279 on ClinicalTrials.gov