Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Study Overview
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Brief Summary
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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
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The study will be carried out in a single study site located in Canada

Official Title
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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

Conditions
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Birch Pollen Allergy

Intervention / Treatment
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* Biological: DM-101PX
* Biological: Placebo to Match DM-101PX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DM-101PX low dose<br>10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. | Biological: DM-101PX<br>* subcutaneous injection of DM-101PX<br>|
| Placebo Comparator: Placebo<br>10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. | Biological: Placebo to Match DM-101PX<br>* Placebo to match DM-101PX administered subcutaneously<br>|
| Experimental: DM-101PX middle dose<br>10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. | Biological: DM-101PX<br>* subcutaneous injection of DM-101PX<br>|
| Experimental: DM-101PX high dose<br>10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. | Biological: DM-101PX<br>* subcutaneous injection of DM-101PX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events | Occurrence of treatment emergent adverse events | 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 | From the first dose to until 14-28 days from the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |