Skip to main content
OpenTrials
Completed

NCT Number: NCT01243008

Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lyme Disease Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Gram-Negative Bacterial Infections Infections Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trials Center, University and University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of SHB001

Drug
  • 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

Other names: 0% SHB001 azitrhomycin dermal formulation (placebo), 5% SHB001 azitrhomycin dermal formulation, 10% SHB001 azitrhomycin dermal formulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Appletree AG
  • Ixodes GmbH

Registry information

Official study 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

Acronym: IXO-01

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2010
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.