First Time in Man Trial for Friulimicin B

This study has been terminated.
(Unfavourable Pharmakokinetics)
Sponsor:
Information provided by:
MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00492271
First received: June 25, 2007
Last updated: July 22, 2008
Last verified: July 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

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
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, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on July 22, 2014