CRC 385 Part B MAD

Would you like to be part of our research looking at an investigational product that would be used to promote nerve damage repair?

 

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 at the site of the injury and this becomes a barrier to recovery as it prevents the nerves growing back in the spinal cord. Current treatments in place for brachial plexus injuries often do not result in full return of functions or sufficient pain relief. Some treatments used involve surgery to implant nerves; this technique has been shown to result in some return of motor function and easing of pain but not return of sensations and it is thought that this may in part be due to the formation of the scar.

 

Results of studies in animals have shown that early administration of KCL-286 (the medication being investigated in this study) prevents a scar from forming where the nerves have been torn from the spinal cord and therefore this allows the nerves to grow back preventing the loss of functions, including the loss of sensations.

 

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.

Your involvement will last for up to 20 days, excluding the screening period. During your time in the study you will be asked to visit the Surrey CRC 4 times. You will initially attend a screening visit to determine your suitability, your second visit will be a 9 day/night residential stay, the third will be a 30 minute appointment and then your final visit will be a post study out-patient appointment 7-12 days after you received your last dose of study medication.

 

During the first visit you will be seen by one of the Research Centre’s study doctors; a full explanation of the study will be given, you will go through the consent process and you will be asked to give details of your medical history during the medical screening. Routine blood tests will be taken to test for HIV, Hepatitis B & C and urine samples taken to test for drugs of abuse and nicotine. Your vital signs (heart rate, breathing rate, blood pressure and oral temperature), and ECG (a recording of the electrical activity of your heart), your height and weight will be measured and the study doctor will perform a routine physical examination including visual assessments to evaluate your health. You will be required to complete questionnaires about your health. If you decide to take part in the study your GP will be contacted, with your permission, in order to notify him/her of your participation.

 

If you pass this screening visit you will be asked to attend for your visit 2, your eligibility criteria will be reassessed and if you still meet the criteria you will stay for the 9 days/nights. During this stay you will be asked to complete questionnaires about mood and alertness, have vision assessments, have full physical and neurological examinations, have your vital signs and ECG taken, blood and urine samples will be collected and any adverse events will be recorded. You will be given the medication you have been randomly assigned to daily for 7 days and asked to swallow this with water. You will be discharged from the Surrey CRC on the morning of Day 9.

                 

You will return to the Surrey CRC for Visit 2a on Day 10 (3 days after you received the last dose of medication). At this visit you will have blood and urine samples collected, and will also be asked about any concomitant medications you may have taken and if you have experienced any adverse effects.

 

You will then return to the Surrey CRC for a final follow up visit, 7 to 12 days after you received the last dose of study medication (days 14-19). At this visit you will have full physical and neurological examinations, review of you concomitant medication, tests of your vision will be performed, you will complete questionnaires about your mood and anxiety, have your vital signs and ECG taken, urine samples taken for urinalysis and to test for the presence of nicotine and prohibited drugs, blood samples taken, a breath alcohol test and any adverse events will be recorded.

 

You will be screened over the telephone in the first instance to assess your suitability and to be advised of all other restrictions; if you wish to participate and the results from the telephone screen identify you as suitable, you will be invited to the centre for a screening visit. You must be registered with a doctor as we will be contacting your GP to inform them of what we are administering, so please bring in your doctor’s details with you for your screening visit. This should include your GPs name, full address, phone and fax numbers. For the initial visit all participants must bring in their passport (and if applicable National Insurance (NI) number).

Participant Requirements 

To be eligible to take part you must be:

You must be a male aged between 19 and 45

You must not have participated in another clinical trial within 3 months of the first treatment period.

You must have an appropriate work permit (if you are not from the EU)

You must have a Body Mass Index of  ≥ 18 kg/m2 to ≤ 30 kg/m2

Be a non-nicotine user (not smoked or used other nicotine products within 3 months before the screening visit)

Have no clinically relevant medical conditions or allergies

Not taking any medications, herbal supplements, vitamins or minerals, except a maximum of 2g of paracetamol per 24 hours

Be willing to avoid direct sunlight, use sun cream, cover your arms and legs and wear a sunhat and sunglasses when outside from the time you receive the study medication until you complete the study

Not have used a sunbed for 3 months before screening and for the duration of the study and one month after you finish taking part in the study

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.

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

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

You are willing to take the study medication or placebo (depending on what you have been randomised to) which contains gelatine.

Be available for every required date for the duration of the study

 

Visit 
Inconvenience Allowance 

You will be reimbursed £1,725 for your time. Reasonable travel expenses of up to £40 will be provided for your visits.

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 www.helpresearch.co.uk

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