Lyme DiseasePhase 1/2IXO-01NCT01243008
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
A Phase 1/2 study testing Application of SHB001 in people with Lyme Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Application of SHB001
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2010to Nov 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Trials Center, University and University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
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
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
Read the 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
- Conditions
- Lyme Disease
- Being tested
- Application of SHB001
- Keywords
- Lyme disease, Borreliosis, Azithromycin
- Medical subject headings
- Lyme Disease, Borrelia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of SHB001Drug
Also called 0% SHB001 azitrhomycin dermal formulation (placebo), 5% SHB001 azitrhomycin dermal formulation, 10% SHB001 azitrhomycin dermal formulation
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2010 - November 2010
Secondary outcomes (1)
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.
Measured: April 2010 - November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ixodes GmbH, Appletree AG
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243008
- Sponsor's protocol ID
- IXO-01
- Acronym
- IXO-01
- Status last verified
- Nov 2010
- First submitted
- 16 Sep 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01243008
- Acronym / sponsor ID
- IXO-01 / IXO-01
- Conditions
- Lyme Disease
- Keywords
- Lyme disease, Borreliosis, Azithromycin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ixodes GmbH, Appletree AG
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of SHB001Also: 0% SHB001 azitrhomycin dermal formulation (placebo), 5% SHB001 azitrhomycin dermal formulation, 10% SHB001 azitrhomycin dermal formulation* 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 | Drug | – |
Primary outcome
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.
1 secondary outcome
Pharmacokinetics of SHB001
Time frame: April 2010 - November 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
Related trials for Lyme Disease
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Application of SHB001 in people with Lyme Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local safety (time frame: April 2010 - November 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.