First Time in Man Trial for Friulimicin B

July 22, 2008 updated by: MerLion Pharmaceuticals GmbH

A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4123
        • Swiss Pharma Contract Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Experimental arm with increasing dosage
Drug: Friulimicin B
Intravenous, once daily, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis.
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects
Time Frame: 5 days
5 days
To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MerLion Pharmaceuticals GmbH

Investigators

  • Principal Investigator: Michael Sieberling, MD, Swiss Pharma Contract

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

July 23, 2008

Last Update Submitted That Met QC Criteria

July 22, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNB-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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