TerminatedPhase 1

First Time in Man Trial for Friulimicin B

Stopped: Unfavourable Pharmakokinetics

Switzerland31 participantsStarted 2007-06

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

Timeframe: 5 days

Trial details

NCT IDNCT00492271

SponsorMerLion Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-09

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