NCT06037148

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Desentum Oy · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Birch Pollen Allergy

Interventions

Type	Name	Description
BIOLOGICAL	DM-101PX	subcutaneous injection of DM-101PX
BIOLOGICAL	Placebo to Match DM-101PX	Placebo to match DM-101PX administered subcutaneously

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-03-06
• Completion: 2024-03-06
• First posted: 2023-09-14
• Last updated: 2024-03-25

Locations

1 site across 1 country: Canada