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

This study has been completed.
Sponsor:
Collaborators:
Ixodes GmbH
Appletree AG
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01243008
First received: September 16, 2010
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.


Condition Intervention Phase
Lyme Disease
Drug: Application of SHB001
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Local safety [ Time Frame: April 2010 - November 2010 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: April 2010 - November 2010 ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 32
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243008

Locations
Switzerland
Clinical Trials Center, University and University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Ixodes GmbH
Appletree AG
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Thomas Kündig, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT01243008     History of Changes
Other Study ID Numbers: IXO-01
Study First Received: September 16, 2010
Last Updated: November 18, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Lyme disease
Borreliosis
Azithromycin

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014