Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.
The study will be carried out in a single study site located in Canada
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
subcutaneous injection of DM-101PX
Placebo to match DM-101PX administered subcutaneously
Cliantha Research
Mississauga, Ontario, Canada
Treatment Emergent Adverse Events
Occurrence of treatment emergent adverse events
Time frame: From the first dose to until 14-28 days from the last dose
Adverse Events of Special Interest
Occurrence of local injection site reactions and systemic allergic reactions
Time frame: From the first dose to until 14-28 days from the last dose
Subjects Reaching the Maximum Intended Dose
Number of subjects in each cohort who reach the maximum intended dose
Time frame: Through the treatment period, an average of 10 weeks
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