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Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation (IXO-01)

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ClinicalTrials.gov Identifier: NCT01243008
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 19, 2010
Sponsor:
Collaborators:
Ixodes GmbH
Appletree AG
Information provided by:
University of Zurich

Tracking Information
First Submitted Date  ICMJE September 16, 2010
First Posted Date  ICMJE November 17, 2010
Last Update Posted Date November 19, 2010
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01243008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
Pharmacokinetics of SHB001 [ Time Frame: April 2010 - November 2010 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
Pharmacokinteics of SHB001 [ Time Frame: April 2010 - November 2010 ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Official Title  ICMJE 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
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lyme Disease
Intervention  ICMJE 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
Other Names:
  • 0% SHB001 azitrhomycin dermal formulation (placebo)
  • 5% SHB001 azitrhomycin dermal formulation
  • 10% SHB001 azitrhomycin dermal formulation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2010)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01243008
Other Study ID Numbers  ICMJE IXO-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Kündig, University Hospital Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE
  • Ixodes GmbH
  • Appletree AG
Investigators  ICMJE
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP