Status:
COMPLETED
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Ixodes GmbH
Appletree AG
Conditions:
Lyme Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 Description
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...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Male or female healthy volunteers, age 18 - 70 years
- Main exclusion criteria:
- A known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics
- A known hypersensitivity against lidocaine
- Treatment by any route with any macrolide antibiotic within the last 2 month
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01243008
Start Date
April 1 2010
End Date
November 1 2010
Last Update
November 19 2010
Active Locations (1)
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1
Clinical Trials Center, University and University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091