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HAL-MRE1 Subcutaneous Immunotherapy in Ragweed Allergic Patients First-in-human

NCT03758456 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-08-06

No results posted yet for this study

Summary

The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma.

The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses of HAL-MRE1.

Conditions

  • Rhinitis, Allergic
  • Rhinoconjunctivitis, Allergic

Interventions

BIOLOGICAL

HAL-MRE1

HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen.

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Peter Couroux, MD · Inflamax Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2019-05-17
Completion
2019-05-17

Countries

  • Canada

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 NCT03758456 on ClinicalTrials.gov