CompletedPhase 1ACTRN12607000260426

A Phase 1 Single-Center, Open-Label Study to Evaluate the Safety and Pharmacokinetics of a Candidate Topical Antimicrobial (NEO101) among Healthy Adult Men

Sponsor

Neosil, Inc

Enrollment

5 participants

Start Date

May 14, 2007

Study Type

Interventional

Conditions

Open-label safety pharmacokinetic study in healthy adult men of topical antimicrobial being developed for the indication of nasal carriage of Staphylococcus aureus.

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.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase 1 safety study evaluates a new topical antimicrobial gel (NEO101) applied to the skin of healthy male volunteers. It is for healthy men aged 18 to 40 in good general health. Participants have the gel applied to their skin and are monitored for any side effects, with blood tests to see how the body processes the product.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Australia

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ACTRN12607000260426