AUT00201 - first doses in humans

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo controlled, single and repeated dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AUT00201 in healthy male and female volunteers. (HMR code: 18-022)

• IRAS ID

  266557

• Contact name

  John Hutchison

• Contact email

  john.hutchison@autifony.com

• Sponsor organisation

  Autifony Therapeutics Limited

• Eudract number

  2019-002160-26

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  AUT00201 (the study medicine) is an experimental new medicine for treating schizophrenia, an illness that affects the way that people think, feel or behave.
  
  We’re not sure what causes schizophrenia, but it’s been linked to chemical imbalances in the brain. We hope that AUT00201 will modulate important areas in the brain to help correct that imbalance. Current treatments don’t always work very well and can cause unpleasant side effects. We hope that AUT00201 will help improve the symptoms of schizophrenia and have fewer side effects than existing medicines. We’re doing this study to find out whether taking single and repeated doses of AUT00201 have any important side effects in healthy men and women when taken by mouth, and whether food affects the blood levels of AUT00201. The study medicine has never been given to humans before, so in each part, we’ll start with a small dose, and increase the dose as the study progresses.

  This is a 2-part study (Parts A1–3 and Part B) in healthy men, aged 18–45, and healthy women, aged 18–65.

  In Part A, we’ll give single doses of AUT00201 to 5 groups of participants: Groups 1–3 in Part A1 (up to 24 healthy men); Part A2 (up to 8 healthy women); and Part A3 (up to 16 healthy men).

  In Part 2, we’ll test repeated doses of AUT00201, in up to 4 groups of 8 participants each.

  Participants will take 8–12 weeks to finish the study. They’ll have 1–4 study sessions and stay on the ward for: up to 3 nights in each session (Part A); or 30 nights (Part B). They’ll make 5–14 outpatient visits.

  A pharmaceutical company (Autifony Therapeutics Limited) is funding the study.

  The study will take place at 1 centre in London.

• REC name

  HSC REC B

• REC reference

  19/NI/0141

• Date of REC Opinion

  30 Aug 2019

• REC opinion

  Favourable Opinion