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Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy

NCT04266028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-03-21

Study results available
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Summary

Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.

Conditions

  • Birch Pollen Allergy

Interventions

BIOLOGICAL

DM-101

DM-101 administered by subcutaneous (SC) injection

BIOLOGICAL

Placebo to match DM-101

Placebo to match DM-101 administered by SC injection

Sponsors & Collaborators

  • Desentum Oy

    lead INDUSTRY

Principal Investigators

  • Anna Nilson · Desentum Oy

  • Mika Scheinin · Clinical Research Services Turku

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
2020-02-11
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Finland

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 NCT04266028 on ClinicalTrials.gov