First Time in Man Trial for Friulimicin B - Full Text View

Sponsored by:	MerLion Pharmaceuticals GmbH
Information provided by:	MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00492271

Purpose

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.

Condition	Intervention	Phase
Community Acquired Pneumonia Staphylococcal Skin Infections	Drug: Friulimicin B	Phase I

MedlinePlus related topics: Pneumonia

Drug Information available for: Friulimicin B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by MerLion Pharmaceuticals GmbH:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	31
Study Start Date:	June 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Experimental arm with increasing dosage	Drug: Friulimicin B Intravenous, once daily, single dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492271

Locations

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

Sponsors and Collaborators

MerLion Pharmaceuticals GmbH

Investigators

Principal Investigator:

Michael Sieberling, MD

Swiss Pharma Contract

More Information

No publications provided

Responsible Party:	SWISS PHARMA CONTRACT LTD, Basel, Switzerland ( Michael Sieberling, MD; Principal Investigator )
Study ID Numbers:	CNB-001
Study First Received:	June 25, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00492271 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by MerLion Pharmaceuticals GmbH:

Friulimicin B
Lipopeptide Antibiotic
First in Man

Study placed in the following topic categories:

Bacterial Infections
Skin Diseases
Staphylococcal Skin Infections
Healthy
Staphylococcal Infections
Anti-Bacterial Agents
Skin Diseases, Infectious

Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Skin Diseases, Bacterial
Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Skin Diseases, Bacterial
Lung Diseases
Staphylococcal Skin Infections
Infection
Pneumonia

ClinicalTrials.gov processed this record on May 06, 2009