CRC 385 SAD Cohorts 6 - 8

Study drug KCL-286 has been designed to treat nerve damage, for example from the trauma possibly caused in a motor cycle accident. These accidents can result in the nerve roots being torn from the spinal cord, known as a brachial plexus injury, when the nerves in the “arm pit” are damaged. In these situations the main effects often seen are problems with movement, loss of sensations and pain. Once the nerves have been torn from the spinal cord a scar is formed on the nerve endings.

This is the first study to give KCL-286 to humans. It will be given to healthy males (who do not have brachial plexus injuries) to investigate whether it has any side effects in humans and also to determine the appropriate doses to investigate in patients with brachial plexus injuries.

To date there have been no related safety concerns from the participants who have received a dose of study drug.

Participant Requirements 
  1. You must be aged between 19 and 45
  2. You must not have participated in another clinical trial within 3 months of the first treatment period.
  3. You must have an appropriate work permit (if you are not from the EU)
  4. You must have a Body Mass Index of  ≥ 18 kg/m2 to ≤ 30 kg/m2
  5. Be a non-nicotine user (not smoked or used other nicotine products within 3 months before the screening visit)
  6. Have no clinically relevant medical conditions or allergies
  7. Not taking any medications, herbal supplements, vitamins or minerals, except a maximum of 2g of paracetamol per 24 hours
  8. Be willing to avoid direct sunlight, use sun cream, cover your arms and legs and wear a sunhat and sunglasses when outside for the duration of the study
  9. Not have used a sunbed for 3 months before screening and for the duration of the study and one month after
  10. Be willing to not consume alcohol, caffeine, xanthine and poppy seed containing food/drinks within 48 hours of each visit. At all other times, be willing to limit caffeine to 500mg per day and alcohol to 21 units per week.
  11. Be willing to not consume grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges for the duration of the study
  12. Be willing to use condoms with spermicide for the duration of the study and for 3 months after the last visit and any female partners should be on an effective form of contraception during this period
  13. You are willing to take the study medication or placebo (depending on what you have been randomised to) which contains gelatine.
  14. Be available for every required date for the duration of the study
Visit 
Date Description Location Duration
Visit 1 - Screening Surrey CRC Approximately 5 hours
Visit 2 - Residential Stay Surrey CRC 3 Nights
Visit 2A - 72 hour post dose Surrey CRC Approximately 30 minutes
Visit 2b - 5 days post dose (Day 6) Surrey CRC Approximately 1 hour
Visit 3- Post Study Visit Surrey CRC Approximately 3 hours
Inconvenience Allowance 

Compensation – £800 (£825 if Visit 2a takes place)

Travel Expenses – Maximum £40 per visit, determined on a zone-by-zone basis

If you need to attend for any additional visits (for example if your screening procedures need to be split on more than one day) you will be reimbursed for your travel for this extra visit.

Interested in taking part? 

If you would like more information under no obligation, or are interested in taking part and wish to complete a telephone health screen, please contact the Clinical Research Recruitment team on: Freephone 0800 269 847, by email crc-recruitment@surrey.ac.uk and if you have not done so already, please register with us on here

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