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A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL

NCT02557633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-03-03

No results posted yet for this study

Summary

There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration.

Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.

Conditions

  • Allergic Rhinitis

Interventions

BIOLOGICAL

Grass MATA MPL 10200

BIOLOGICAL

Grass MATA MPL 18200

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Inflamax Research Incorporated

    collaborator INDUSTRY

  • Metronomia Clinical Research GMBH

    collaborator UNKNOWN

  • Allergy Therapeutics

    lead INDUSTRY

Principal Investigators

  • Tim Higenbottam, DSc MD FRCP FFPM · Allergy Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02557633 on ClinicalTrials.gov