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.
The study will be carried out in a single study site located in Finland.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
27
DM-101 administered by subcutaneous (SC) injection
Placebo to match DM-101 administered by SC injection
Clinical Research Services Turku
Turku, Finland
Treatment Emergent Adverse Events
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
Time frame: From the first dose until 28 days following the last dose.
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.
Time frame: From the first dose until 28 days following the last dose.
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol.
Time frame: From the first dose until 28 days following the last dose.
Subjects Reaching the Pre-defined DM-101 Dose
Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group
Time frame: From the first dose until 28 days following the last dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.