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First received: November 02, 2023

Clinical Trial: Phase 1, SAD/MAD of Verasone™ Administered by Sinonasal Irrigation in Healthy Participants

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Volunteers

Study Type: INTERVENTIONAL


Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Verasone™ Administered by Sinonasal Irrig

Brief Summary: Verasone™ is an aqueous suspension of the combination of two marketed drugs to be dosed by sinonasal irrigation in the treatment of Chronic Rhinosinusitis (CRS).This Phase 1 first-in-human study will assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of Verasone versus placebo in healthy normal participants and will evaluate the PK profiles of the Verasone active components administered individually vs in combination.

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