A Phase 1 Single-Center, Open-Label Study to Evaluate the Safety and Pharmacokinetics of a Candidate Topical Antimicrobial (NEO101) among Healthy Adult Me
Phase 1
Completed
- Conditions
- Open-label safety pharmacokinetic study in healthy adult men of topical antimicrobial being developed for the indication of nasal carriage of Staphylococcus aureus.Infection - Studies of infection and infectious agents
- Registration Number
- ACTRN12607000260426
- Lead Sponsor
- eosil, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the safety, including pharmacokinetic monitoring, of three-times-daily topical nasal application of NEO101 for 3 days among healthy adult men.[Pharmacokinetic blood sampling will be done on Days 1, 4-7, 8 and 10.]
- Secondary Outcome Measures
Name Time Method one.[None.]