A first in man study of KCL-286 in healthy male participants

• Research type

  Research Study

• Full title

  A Phase I, prospective, double-blind, randomised, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KCL-286 and the effects of food in healthy male participants

• IRAS ID

  243677

• Contact name

  Tim Mant

• Contact email

  tim.mant@kcl.ac.uk

• Sponsor organisation

  Kings College London

• Eudract number

  2018-000076-15

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  This study will be investigating a new medicine that has not previously been given to humans. Results from animal studies suggest the medication could be beneficial in treating nerve damage resulting from injuries to the arm (brachial plexus injuries).

  This study will be a randomised dose escalation study conducted at one site in the UK (a Phase I accredited Unit). The medication will be given to healthy males to investigate whether it has any side effects in humans, to determine how humans handle the drug (pharmacokinetics) by measuring e.g. drug levels in the blood, and how the drug affects the body (pharmacodynamics) e.g. by measuring tissue plasminogen activator, a protein, in the blood which may indicate a potentially useful pharmacological effect.
  There will be three parts to this trial:
  A1. Single ascending doses of the study medication to different cohorts
  A2. Investigating the impact of food on the study medication
  B. Multiple ascending doses of the study medication to different cohorts

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  18/LO/0460

• Date of REC Opinion

  9 May 2018

• REC opinion

  Further Information Favourable Opinion