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Trial record 29 of 64 for:    lyme

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:
Information provided by:

September 16, 2010
November 17, 2010
November 19, 2010
April 2010
November 2010   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01243008 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
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
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.

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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Lyme Disease
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01243008
IXO-01
Yes
Not Provided
Not Provided
Thomas Kündig, University Hospital Zurich
University of Zurich
  • Ixodes GmbH
  • Appletree AG
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
November 2010

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