NCT01243008

Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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: 1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation. 1. Treatment of cohort 1 with azithromycin dermal formulation and follow up 2. Assessment of local safety within the 7 days following the first treatment 3. The maximal tolerated dose (MTD) will be determined 2. 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. 1. 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 2. Skin biopsies of treated skin areas will be taken for the PK assessment 3. Study completion examination

Conditions

• Lyme Disease

Interventions

Type	Name	Description
DRUG	Application of SHB001	* Cohort 1: Application of SHB001 on the skin of right thigh * Cohort 2: 1. Application of SHB001 on the skin of right thigh 2. punch biopsies of treated skin areas

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-11-17
• Last updated: 2010-11-19

Locations

1 site across 1 country: Switzerland