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First Time in Man Trial for Friulimicin B

NCT ID: NCT00492271

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Detailed Description

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Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.

This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Conditions

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Community Acquired Pneumonia Staphylococcal Skin Infections

Keywords

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Friulimicin B Lipopeptide Antibiotic First in Man

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Experimental arm with increasing dosage

Group Type EXPERIMENTAL

Friulimicin B

Intervention Type DRUG

Intravenous, once daily, single dose

Interventions

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Friulimicin B

Intravenous, once daily, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female healthy subjects
* 18-55 years of age
* In good health

Exclusion Criteria

* Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MerLion Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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SWISS PHARMA CONTRACT LTD, Basel, Switzerland

Principal Investigators

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Michael Sieberling, MD

Role: PRINCIPAL_INVESTIGATOR

Swiss Pharma Contract

Locations

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Swiss Pharma Contract Ltd

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CNB-001

Identifier Type: -

Identifier Source: org_study_id