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Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM

NCT02156791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-06-06

No results posted yet for this study

Summary

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this clinical trial is to confirm the safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated dose of gpASIT+TM .

Conditions

  • Hay Fever

Interventions

BIOLOGICAL

gpASIT+TM

Sponsors & Collaborators

  • BioTech Tools S.A.

    lead INDUSTRY

Principal Investigators

  • Bettina Hauswald, MD · Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Germany

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 NCT02156791 on ClinicalTrials.gov