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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06037148
Other study ID # DM-101-C-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 7, 2023
Est. completion date March 6, 2024

Study information

Verified date March 2024
Source Desentum Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 6, 2024
Est. primary completion date March 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Biological:
DM-101PX
subcutaneous injection of DM-101PX
Placebo to Match DM-101PX
Placebo to match DM-101PX administered subcutaneously

Locations

Country Name City State
Canada Cliantha Research Mississauga Ontario

Sponsors (1)

Lead Sponsor Collaborator
Desentum Oy

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Emergent Adverse Events Occurrence of treatment emergent adverse events From the first dose to until 14-28 days from the last dose
Primary Adverse Events of Special Interest Occurrence of local injection site reactions and systemic allergic reactions From the first dose to until 14-28 days from the last dose
Secondary Subjects Reaching the Maximum Intended Dose Number of subjects in each cohort who reach the maximum intended dose Through the treatment period, an average of 10 weeks
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