Safety, blood levels and effects of AUT00063: first doses in humans;v1

• 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 AUT00063 in healthy young men and older men and women (HMR code: 12-024)

• IRAS ID

  126727

• Contact name

  Gary Peters

• Sponsor organisation

  Autifony Therapeutics Limited

• Eudract number

  2013-000459-42

• Research summary

  AUT00063 (the study medicine) is an experimental new medicine for treating hearing problems, such as loss of hearing or tinnitus (a buzzing noise in the ears). Hearing problems are common in older people and have become more common in young people. There are currently no medicines available for them. Hearing loss has been linked to reduced activity at certain sites in the brain. We hope that the study medicine increases the activity at those sites. In this 2-part study (Parts A and B), we aim to assess side effects, blood levels, and effects of the study medicine.In Part A, We'll give up to 24 healthy young men, aged 18??45 years, up to 5 single doses of the study medicine by mouth. It??s never been given to humans before, so We'll start with a small dose, and increase the dose as the study progresses. Participants will take up to 15 weeks to finish the study. They??ll make up to 7 outpatient visits, and stay on the ward for up to 15 nights in total (up to 5 stays: 3 nights each).In Part B, We'll give 24 healthy young men, aged 18??45 years, and 18 older men and women, aged 60??75 years, daily doses of the study medicine for up to 28 days. Participants will take up to 10 weeks to finish the study. They??ll make up to 4 outpatient visits, and stay on the ward 15??29 nights in a row, depending on how long we expect it to take until blood levels of the study medicine level off. A pharmaceutical company (Autifony Therapeutics Limited) is funding the study.The study will take place in 1 centre in London. We'll recruit participants by: advertising (newspaper, radio, and websites); word of mouth; volunteer databases; and our websites.

• REC name

  Scotland A REC

• REC reference

  13/SS/0035

• Date of REC Opinion

  26 Mar 2013

• REC opinion

  Favourable Opinion