DISCOVER A NEW WAY TO HELP
If you are a healthy male or female (of non-childbearing potential) aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a treatment being developed for Dementia.
Inconvenience Payment of £3700. (Plus additional travel expenses)
CLINICAL TRIAL information
Simbec-Orion Clinical Pharmacology is currently running to investigate a study drug, DNL593.
DNL593 is being developed for the treatment of a condition called frontotemporal dementia (FTD).
This type of dementia is the most common form of dementia in people under 60 years of age and is a long-term progressive condition of the nervous system whereby there is an accumulation of proteins in certain cells in the brain, leading to death of these cells.
Currently there are no effective treatments for FTD which can cure or slow down the progression of the disease; only treatments which aim to control some of the symptoms. Therefore, there is an unmet need to develop treatments which may be more effective in managing FTD such as DNL593 which is being evaluated in this study
The main objectives of the first part of this study (Part A) are as follows:
- To determine the safety and tolerability of DNL593 when it is administered as a single dose on one occasion at different dose strengths and by different routes of administration.
- To investigate the concentration of DNL593 in the blood, how this changes over a period of time.
- To investigate the concentration of DNL593 in the fluid surrounding the brain and spinal cord, and to evaluate whether there are differences in the concentration between different dose strengths of DNL593 and between different routes of administration.
We will also investigate, as exploratory objectives, the effect of DNL593 on the body by analysing the levels of certain biomarkers in the body and will evaluate the immune system response to DNL593 through the measurement of anti-drug antibodies.
Part A will consist of 8 planned groups of 8 healthy volunteer participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group.
If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) for the initial treatment period, then return for four outpatient return visits (separated by approximately 7 days each) up to Day 28 and then attend a final post study follow-up visit after the dose of DNL593 (Day 84).
Blood samples will be taken at set time points throughout this part of the study in order to measure the amount of DNL593 in the blood and the CSF. We will compare the results from each of the groups to determine if there are any significant differences in the profile of DNL593, amount of DNL593 in the blood and CSF, how this changes over time.
The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in the development of the study drug DNL593.
CLINICAL TRIAL timeline
If you complete this study, you will receive a maximum inconvenience payment of £3700.
This payment is split into 5 parts: £750 after completion of the Day 7 visit, £250 after completion of the Day 14 visit, £250 after completion of the Day 21 visit, £500 after completion of the Day 28 visit and the remaining £1950 after completion of the Day 84 visit.
We also pay additional travel expenses for every visit.
Thank you for your time to register your interest in this trial please complete the below form.
OR to speak to a member of the Enrolment Team for more information or regarding any questions or queries please ring 0800 691995 and please select option 1. Alternatively drop us an email: email@example.com