This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of BLU-808 in participants with ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). Participants will undergo eligibility assessments that include exposure to ragweed pollen in an allergen exposure chamber (AEC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Red Maple Trials
Ottawa, Canada
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 56
Area Under the Curve (AUC) of BLU-808
Time frame: Day 1 to Day 28
Maximum Plasma Concentration (Cmax) of BLU-808
Time frame: Day 1 to Day 28
Minimum Plasma Concentration (Cmin) of BLU-808
Time frame: Day 1 to Day 28
Apparent Clearance (CL/F) of BLU-808
Time frame: Day 1 to Day 28
Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Time frame: Day 1 to Day 28
Terminal Half-life (t½) of BLU-808
Time frame: Day 1 to Day 28
Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 14, Day 28
Change in Baseline-adjusted AUC of the TNSS
Time frame: Baseline, Day 14, Day 28
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