A Safety, Tolerability, PK and PD Study of BCX10013

• Research type

  Research Study

• Full title

  A Phase I First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of BCX10013 in Healthy Subjects

• IRAS ID

  300091

• Contact name

  Sharan Sidhu

• Contact email

  sharan.sidhu@quotientsciences.com

• Sponsor organisation

  BioCryst Pharmaceuticals, Inc.

• Eudract number

  2021-002628-19

• ISRCTN Number

  ISRCTN11493328

• Duration of Study in the UK

  0 years, 8 months, 15 days

• Research summary

  Summary of Research
  The Sponsor is developing a new test medicine, BCX10013, to treat diseases related to the immune system.\n\nThis is a 3-Part, single-centre, randomised study that will try to assess the safety and tolerability of the test medicine, alongside how it is taken up by the body and how the body affects the test medicine, when taken as a single or daily oral dose. This is a first-in-human study in healthy male and female volunteers, aged 18 - 55. \n\nIn Part 1, volunteers will be split into groups and will receive single doses of the test medicine or dummy medicine (placebo), at different dose levels. One group will be testing the effect of food on the test medicine, so some volunteers in this group will be dosed in the fed state.\n\nIn Part 2, groups of volunteers will receive the test medicine, at different dose levels, or placebo once or twice daily for up to 14 consecutive days. \n\nPart 3 will enrol Japanese volunteers. One group of volunteers will receive a single dose of the test medicine or placebo, and the other group will receive the test medicine or placebo once or twice daily for up to 14 consecutive days. \n\n\n

  Summary of Results
  The Sponsor has confirmed to the HRA and REC that the trial is currently being registered on the ISRCTN platform, with the primary results expected to be posted in January 2025. Following this, the Sponsor will also provide a lay summary of results to the HRA for publishing alongside the research summary record on the HRA website.

• REC name

  Wales REC 2

• REC reference

  21/WA/0192

• Date of REC Opinion

  10 Jun 2021

• REC opinion

  Favourable Opinion