None listed
Conditions
Brief summary
This study will evaluate the safety, including blood sampling for pharmacokinetic monitoring, of a new topical anti-infective (NEO101) applied to each nostril. A single dose will be applied on Day 1 and Day 7 of the study, and three-times-daily doses will be applied on Days 4, 5 and 6.
Interventions
On Day 1 and Day 7 subjects will receive a single topical application of NEO101 to each nostril. On Day 4 through Day 6 subjects will receive a treatment course of three-times-daily topical application of NEO101 to each nostril. Each application consists of 0.1mL 0.95% NEO101 per nostril. Pharmacokinetic blood sampling will be done on Days 1, 4-7, 8 and 10. Safety evaluations will be performed during the treatment course and for 14 days following treatment.
Sponsors
Neosil, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Subjects, in general good health, compliant with (defined) birth control.
Exclusion criteria
Subjects have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug, have clinical evidence of active cutaneous infection, have had skin or soft tissue infection with S. aureus within 30 days prior to enrollment, have documented disruption of the nasal or facial bones, have atopic dermatitis/eczema, allergic rhinitis, nasal polyps or nasal piercings, have a history of hypersensitivity or allergic reactions to parabens, sodium sulfite or any other ingredient in the formulation.
Outcome results
None listed