Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

Lyme Disease Clinical Trial

— IXO-01  

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 Repeated Applications on the Skin of Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243008
• Other study ID #: IXO-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2010
• Last updated: November 18, 2010
• Start date: April 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Drug:
• Application of SHB001
Cohort 1: Application of SHB001 on the skin of right thigh Cohort 2: Application of SHB001 on the skin of right thigh punch biopsies of treated skin areas

Locations

Country	Name	City	State
Switzerland	Clinical Trials Center, University and University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Appletree AG, Ixodes GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local safety	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.	April 2010 - November 2010	Yes
Secondary	Pharmacokinetics of SHB001	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.	April 2010 - November 2010	Yes