Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation (IXO-01)
Primary Purpose
Lyme Disease
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Application of SHB001
Sponsored by
About this trial
This is an interventional treatment trial for Lyme Disease focused on measuring Lyme disease, Borreliosis, Azithromycin
Eligibility Criteria
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
Sites / Locations
- Clinical Trials Center, University and University Hospital Zurich
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01243008
First Posted
September 16, 2010
Last Updated
November 18, 2010
Sponsor
University of Zurich
Collaborators
Ixodes GmbH, Appletree AG
1. Study Identification
Unique Protocol Identification Number
NCT01243008
Brief Title
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
Collaborators
Ixodes GmbH, Appletree AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Lyme disease, Borreliosis, Azithromycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Application of SHB001
Other Intervention Name(s)
0% SHB001 azitrhomycin dermal formulation (placebo), 5% SHB001 azitrhomycin dermal formulation, 10% SHB001 azitrhomycin dermal formulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Local safety
Description
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.
Time Frame
April 2010 - November 2010
Secondary Outcome Measure Information:
Title
Pharmacokinetics of SHB001
Description
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.
Time Frame
April 2010 - November 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials Center, University and University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
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