First Time in Man Trial for Friulimicin B

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Community Acquired Pneumonia, Staphylococcal Skin Infections

Intervention / Treatment
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* Drug: Friulimicin B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental arm with increasing dosage | Drug: Friulimicin B<br>* Intravenous, once daily, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Friulimicin B, Lipopeptide Antibiotic, First in Man