NCT03887026

Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Efficacy and Safety of Single Doses of Norketotifen in Adult Subjects With Allergen-Induced Allergic Rhinitis in an Allergen Challenge Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Emergo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis.

Detailed description

This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic rhinitis in an allergen challenge chamber.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Norketotifen	Norketotifen oral capsule
DRUG	Placebo	Placebo oral capsule

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-05-18
• Completion: 2019-05-29
• First posted: 2019-03-22
• Last updated: 2020-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study