None listed
Conditions
Brief summary
Betahistine dihydrochloride administered off-label intranasally is an experimental drug being investigated for its potential as a treatment for otitis media with effusion for this clinical trial. lt is hoped that this information will lead to improved clinical management of this condition.
Interventions
Single ascending dose of a betahistine dihydrochloride or placebo administered intranasally in healthy male and female volunteers. The dose levels planned for this study are 10, 20 and 40 mg in 3 cohorts. 8 participants in each cohort will be dosed with either the test medication or placebo in a double-blind manner. The duration of each cohort is 7 days post dose.
Sponsors
Otifex Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female volunteers having Body Mass Index (MBI) between 18 and 30kg/m2 inclusive. Normal (Type A) tympanometric measurements at screening consistent with the normal healthy adult population.
Exclusion criteria
History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease; any acute infectious disease or signs of acute illness, especially of the ear, nose or throat (ENT). History of recurrent ENT infections, irritation or localized reaction to intranasally applied agents. Recent ENT surgery (within 3 months of screening).
Outcome results
None listed