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

NCT06037148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Birch Pollen Allergy

Interventions

BIOLOGICAL

DM-101PX

subcutaneous injection of DM-101PX

BIOLOGICAL

Placebo to Match DM-101PX

Placebo to match DM-101PX administered subcutaneously

Sponsors & Collaborators

  • Desentum Oy

    lead INDUSTRY

Principal Investigators

  • Anna Nilson · Desentum Oy

  • Patricia Couroux · Cliantha Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2024-03-06
Completion
2024-03-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037148 on ClinicalTrials.gov