This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Phase IIa study of PC945 in Aspergillosis in Cystic Fibrosis patients

  • Research type

    Research Study

  • Full title

    An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection

  • IRAS ID

    248009

  • Contact name

    Joseph Stuart Elborn

  • Contact email

    j.elborn@imperial.ac.uk

  • Sponsor organisation

    Pulmocide Ltd

  • Eudract number

    2018-000243-87

  • Duration of Study in the UK

    1 years, 2 months, 2 days

  • Research summary

    This is an open label study (where the participants will know that they are receiving the study drug), to look at the safety and effects of taking PC945 (study drug), by inhaler, to treat participants with a common airborne fungal infection, who also have Cystic Fibrosis. It will also look at how the body breaks down the study drug, the effect that the study drug has on the participant’s lung infection, and how well the participant’s lungs work.

    Up to 18 participants are to be recruited, from sites in the UK.

    Participants are expected to take part in the study for approximately 16 weeks. The study is split into three phases, consisting of
    1. a screening phase of up to 4 weeks;
    2. a 28 day treatment phase; and
    3. an 8 week follow up phase.

    Participants will be expected to make a total of 5 visits to their study centre. In addition, participants will be contacted, by telephone, by study staff on three occasions during the treatment phase.

    The study drug will no longer be available to participants at the end of the treatment phase, as it will still be being tested.

  • REC name

    East of Scotland Research Ethics Service REC 2

  • REC reference

    18/ES/0124

  • Date of REC Opinion

    10 Oct 2018

  • REC opinion

    Favourable Opinion