First Time in Man Trial for Friulimicin B

NCT00492271 | Terminated Phase 1

• 1 other identifier: CNB-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Acquired Pneumonia; Staphylococcal Skin Infections

Keywords

Friulimicin B; Lipopeptide Antibiotic; First in Man

Outcome Measures

Primary Outcomes (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.

  5 days

Secondary Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

Experimental arm with increasing dosage

Drug: Friulimicin B

Interventions

Friulimicin B DRUG

Intravenous, once daily, single dose

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy subjects
• years of age
• In good health

You may not qualify if:

• Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.

Sponsors & Collaborators

• MerLion Pharmaceuticals GmbH: lead

Study Sites (1)

Swiss Pharma Contract Ltd

Basel, CH-4123, Switzerland

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Staphylococcal Skin Infections

Interventions

friulimicin B

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Sieberling, MD

  Swiss Pharma Contract

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 23, 2008

Record last verified: 2008-07

Locations

CH (1)