Single to multiple dose escalation study of PT1.2 in healthy males

  • Research type

    Research Study

  • Full title

    A Phase I, Randomised, Double-Blind, Placebo-Controlled, Sequential Single to Multiple Dose Escalation Study to Assess the Safety and Tolerability of PT1.2 given as one application into each nostril in S.aureus Carrier/Non-carrier Populations of Healthy Subjects.

  • IRAS ID

    16751

  • Eudract number

    2008-006565-85

  • ISRCTN Number

    N/A

  • Clinicaltrials.gov Identifier

    N/A

  • Research summary

    The drug tested in this study is coded as PT1.2. It is being developed by Phico Therapeutics Ltd as a novel antibiotic for the eradication of both methicillin sensitive and methicillin resistant (MRSA) strains of Staphylococcus aureus from the nose of healthy carriers. This study is a randomized (each subject will receive treatment in a random fashion), double blind (neither the subject nor the research staff know which treatments are being received), placebo (inactive treatment) controlled study. The study will take place at Charles River Laboratories in Edinburgh. The main purpose of this study is to assess how safe it is to administer PT1.2 into the nostrils of healthy male subjects aged between 18 and 55 years. The design of the study is that 16 subjects (8 S. aureus carriers and 8 non-carriers) will receive either PT1.2 or placebo as a single low dose. If it is considered safe then a second, same sized group of subjects will receive either PT1.2 or placebo as a single high dose. Again if it is considered safe then a third group of subjects will receive multiple doses (twice daily for 5 days) of either PT1.2 (10 subjects) or placebo (2 subjects). How tolerable the treatment is will also be assessed, for example whether it causes nasal irritation. Another purpose is to study the absorption of the drug from the nose into the body after single and multiple doses. As this study is a healthy volunteer study there is not expected to be any benefit for participating subjects. A full programme of laboratory studies has been completed on this drug to investigate its suitability to give to humans and will be reviewed by the MHRA and an Ethics Committee before the study starts. This is the first study in humans.

  • REC name

    Scotland A REC

  • REC reference

    09/IEC02/1

  • Date of REC Opinion

    8 May 2009

  • REC opinion

    Favourable Opinion