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First Time in Man Trial for Friulimicin B

This study has been terminated.
(Unfavourable Pharmakokinetics)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492271
First Posted: June 27, 2007
Last Update Posted: July 23, 2008
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.
Information provided by:
MerLion Pharmaceuticals GmbH
  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 1

Study Type: Interventional
Study Design: 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

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
Experimental: 1
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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Sieberling, MD; Principal Investigator, SWISS PHARMA CONTRACT LTD, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00492271     History of Changes
Other Study ID Numbers: CNB-001
First Submitted: June 25, 2007
First Posted: June 27, 2007
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:
Pneumonia
Skin Diseases, Infectious
Staphylococcal Skin Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial