A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy

Desentum Oy1 site in 1 country30 target enrollmentSeptember 7, 2023

ConditionsBirch Pollen Allergy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Birch Pollen Allergy
Sponsor: Desentum Oy
Enrollment: 30
Locations: 1
Primary Endpoint: Treatment Emergent Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

The study will be carried out in a single study site located in Canada

Registry

clinicaltrials.gov

Start Date

September 7, 2023

End Date

March 6, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Desentum Oy

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Either sex or any race, aged 18 to 65 years
•Good general health
•A documented clinical history of moderate to severe birch pollen induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over at least 2 previous birch pollen seasons
•Birch pollen specific IgE ≥ 0.7 kU/L
•Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm
•Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2

Exclusion Criteria

•History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial
•Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening
•Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season
•History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past
•A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value
•History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause