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A Study of Tolerability and Safety of a New Cumulative Dose of Grass MATA MPL

NCT03931993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-30

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. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. 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 take forward for further development.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

BIOLOGICAL

Placebo comparator

BIOLOGICAL

Grass MATA MPL

Sponsors & Collaborators

  • SynteractHCR

    collaborator INDUSTRY

  • Metronomia Clinical Research GMBH

    collaborator UNKNOWN

  • Allergy Therapeutics

    lead INDUSTRY

Principal Investigators

  • Tim Higenbottam, MD, FRCP · 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
2017-01-16
Primary Completion
2017-04-27
Completion
2017-04-27
FDA Drug
Yes

Countries

  • United States

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 NCT03931993 on ClinicalTrials.gov