Rhinitis, Allergic Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of HAL-MRE1 Subcutaneous Immunotherapy in Adult Subjects With Ragweed Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
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.
A chemically modified, aluminum hydroxide adsorbed ragweed extract (HAL-MRE1) for
subcutaneous administration was developed for the treatment of ragweed pollen-induced
allergic rhinitis/rhinoconjunctivitis (ARC) with or without asthma. 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 ARC with or
without asthma.
The study will consist of 3 staggered cohorts of 15 subjects each who are randomly assigned
to the active or placebo group in a 2:1 manner using block randomization.
A one month gap must be maintained between the end of the ragweed pollen peak season (2018)
and subject randomization into the study. The study has seasonal constraints; subjects with
concomitant tree and/or grass pollen allergies must complete study treatment before any
allergy symptoms due to tree and/or grass pollen exposure develop or start study treatment
after the symptoms caused by the tree and/or grass pollen exposure have disappeared.
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