Finafloxacin IV SAD MAD

• Research type

  Research Study

• Full title

  FINA-006 - An Investigator and Subject-blind, Placebo-controlled, Randomised, Dose-escalating, Crossover Study to Determine the Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

• IRAS ID

  58106

• Contact name

  Joseph Chiesa

• Sponsor organisation

  MerLion Pharmaceuticals GmbH

• Eudract number

  2010-021555-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Finafloxacin is a new drug being developed for the treatment of bacterial infections and belongs to the fluoroquinolone class. Marketed fluoroquinolone antibiotics include ciprofloxacin and moxifloxacin. Finafloxacin has previously been tested in healthy volunteers as an oral dose. The proposed study will investigate the safety and tolerability of finafloxacin and will investigate the rate at which the drug is removed from the body following administration as an intravenous dose (given directly into a vein via a plastic tube). The study will be divided into two parts. Part AEighteen subjects will be included in two groups (Groups 1 and 2) in Part A of the study. In both groups, each subject will take part in 3 treatment periods. At each treatment period subjects will be chosen at random to receive a single intravenous dose of the finafloxacin or placebo. Part BA total of thirty subjects will be included Groups 3, 4 and 5 in Part B. Subjects will be chosen at random to receive once daily intravenous doses of finafloxacin or placebo for seven days at one treatment period. Subjects in Groups 1, 3 and 4 will be healthy male or female volunteers. Subjects in Groups 2 and 5 will all be healthy female volunteers. All female volunteers will be of non-child bearing potential. At all treatment periods, subjects will check into the research unit the day before dosing and will be discharged from the unit approximately two days after completion of dosing. While resident in the unit subjects will be monitored for adverse events and changes in safety evaluations. In addition, blood and urine samples will be taken for measurement of drug concentrations. All subjects will attend the unit for post-study safety assessments between five and seven days after their last dose.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/21

• Date of REC Opinion

  12 Aug 2010

• REC opinion

  Further Information Favourable Opinion