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 Repeated Applications on the Skin of Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Local safety
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Main inclusion criteria:
- •Male or female healthy volunteers, age 18 - 70 years
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
Outcomes
Primary Outcomes
Local safety
Time Frame: April 2010 - November 2010
The primary objective of this study is to assess the local safety of azithromycin dermal formulation when applied to healthy skin in healthy volunteers. This will be done by determination (in cohort 1) and confirmation (in cohort 2) of the maximal tolerated dose (MTD) after dermal application of SHB001 in 4 different dose regimens.
Secondary Outcomes
- Pharmacokinetics of SHB001(April 2010 - November 2010)