First Time in Man Trial for Friulimicin B

Sponsor

MerLion Pharmaceuticals GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT00492271

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia Staphylococcal Skin Infections	Drug: Friulimicin B	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Experimental arm with increasing dosage

Drug: Friulimicin B

Intravenous, once daily, single dose

Outcome Measures

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. [5 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Swiss Pharma Contract Ltd	Basel		Switzerland	CH-4123

Sponsors and Collaborators

MerLion Pharmaceuticals GmbH

Investigators

Principal Investigator: Michael Sieberling, MD, Swiss Pharma Contract

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00492271

Other Study ID Numbers:

CNB-001

First Posted:

Jun 27, 2007

Last Update Posted:

Jul 23, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

Friulimicin B

Lipopeptide Antibiotic

First in Man

Additional relevant MeSH terms:

Cellulitis

Skin Diseases, Infectious

Staphylococcal Skin Infections

Study Results

No Results Posted as of Jul 23, 2008