None listed
Conditions
Brief summary
The study is a double-blind trial to evaluate the safety and efficacy of RT001 compared to placebo in subjects with allergic rhinitis who test positive to rye grass. Previously reported studies conducted with a similar compound have shown reduction of the typical symptoms of seasonal allergy.
Interventions
Arm 1: Single 5 ng dose of RT001 Topical Gel applied to the nasal cavity. The dose is applied only once
Arm2: Single dose of Placebo Topical Gel applied to the nasal cavity. The dose is applied only once
Sponsors
INC Research Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Seasonal allergic rhinitis reactive to rye grass allergen on skin prick test Total nasal symptom score of at least 7 (scale 0-12)
Exclusion criteria
Nasal disease such as sinusitis, polyps, or nasal structural abnormalities likely to affect application of medication Bacterial or viral infection within 14 days of screening Nasal surgery within 1 year Active asthma requiring medication more than 3 times per week or significant pulmonary disease within 1 year Frequent use of high doses of anti-inflammatory drugs within 2 weeks of treatment or antibiotics within 4 weeks Current use of aminoglycoside or other agents that might interfere with neuromuscular transmission Previous treatment with botulinum toxin or history of botulism Neurological condition that might place subject at increased risk with exposure to Botulinum Toxin Type A
Outcome results
None listed