NCT01111279

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: BioTech Tools S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2010-04-27
• Last updated: 2011-03-01

Locations

1 site across 1 country: Belgium