Clinical Trial: Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Centre, Randomized, Investigator Blinded, Placebo-controlled Ascending Dose Study to Assess the Local Safety, the Skin and Plasma Concentration of Azithromycin Dermal Formulation During Repea
Brief Summary: IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
Detailed Summary:
In this study two consecutive cohorts will be treated:
- Cohort 1: 8 volunteers
- Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each
The study will be conducted in the following three phases:
-
Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.
- Treatment of cohort 1 with azithromycin dermal formulation and follow up
- Assessment of local safety within the 7 days following the first treatment
- The maximal tolerated dose (MTD) will be determined
-
Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.
- Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (MTD), with a dose one or more concentrations lower than maximal tolerated dose (MTD) and with placebo
- Skin biopsies of treated skin areas will be taken for the PK assessment
- Study completion examination
Sponsor: University of Zurich
Current Primary Outcome: Local safety [ Time Frame: April 2010 - November 2010 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Pharmacokinetics of SHB001 [ Time Frame: April 2010 - November 2010 ]
- To assess the pharmacokinetics of azithromycin dermal formulation in the plasma in healthy volunteers after daily administration for three consecutive days in cohort 1 and cohort 2.
- To assess the pharmacokinetics of azithromycin dermal formulation in the skin in healthy volunteers after daily administration for 1 - 3 consecutive days in cohort 2 only.
- To demonstrate that the Minimal Inhibitory Concentration (MIC) of B.b. (=0.03μg/ml) in the skin is reached at least for 2 consecutive assessments (biopsies) in cohort 2.
- To assess general safety in cohort 1 and 2.
Original Secondary Outcome: Pharmacokinteics of SHB001 [ Time Frame: April 2010 - November 2010 ]
- To assess the pharmacokinetics of azithromycin dermal formulation in the plasma in healthy volunteers after daily administration for three consecutive days in cohort 1 and cohort 2.
- To assess the pharmacokinetics of azithromycin dermal formulation in the skin in healthy volunteers after daily administration for 1 - 3 consecutive days in cohort 2 only.
- To demonstrate that the Minimal Inhibitory Concentration (MIC) of B.b. (=0.03μg/ml) in the skin is reached at least for 2 consecutive assessments (biopsies) in cohort 2.
- To assess general safety in cohort 1 and 2.
Information By: University of Zurich
Dates:
Date Received: September 16, 2010
Date Started: April 2010
Date Completion:
Last Updated: November 18, 2010
Last Verified: November 2010