First Time in Man Trial for Friulimicin B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492271
Recruitment Status : Terminated (Unfavourable Pharmakokinetics)
First Posted : June 27, 2007
Last Update Posted : July 23, 2008
Information provided by:
MerLion Pharmaceuticals GmbH

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 Type : Interventional  (Clinical Trial)
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 : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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

Primary Outcome Measures :
  1. 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 :
  1. To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects [ Time Frame: 5 days ]
  2. To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B [ Time Frame: 5 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492271

Swiss Pharma Contract Ltd
Basel, Switzerland, CH-4123
Sponsors and Collaborators
MerLion Pharmaceuticals GmbH
Principal Investigator: Michael Sieberling, MD Swiss Pharma Contract

Responsible Party: Michael Sieberling, MD; Principal Investigator, SWISS PHARMA CONTRACT LTD, Basel, Switzerland Identifier: NCT00492271     History of Changes
Other Study ID Numbers: CNB-001
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: July 23, 2008
Last Verified: July 2008

Keywords provided by MerLion Pharmaceuticals GmbH:
Friulimicin B
Lipopeptide Antibiotic
First in Man

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Skin Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial