Clinical trial summary
In this clinical trial we are recruiting healthy male and female participants aged 18 to 40. This clinical trial aims to evaluate how safe and tolerable different doses of the study medication will be in your body. It also evaluates how the body absorbs, breaks down and excretes the study medication (pharmacokinetics) as well as the effect of the study medication on vitamin A and certain protein (Transthyretin) levels in the blood (pharmacodynamics). If the trials are successful and this study medicine is approved, it would be used to treat people with aTTR amyloidosis.
If you are interested in participating in the trial:-
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment we will take blood samples, check your heart function, and carry out a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve a stay of six days / five nights in our clinical research unit.
- After your stay with us, you will be required to return for further appointments on Day 8, Day 15, Day22, Day 29, Day 43, Day 57, Day 90, Day 180, Day 270, Day 315, and Day 360 of the trial.
- In total, if you are included (receive the study medicine) in the clinical trial you will come to the research unit 13 times over a period of 20 months.
- During your stay with us you will receive a single dose of the study medicine by injection under the skin and we will conduct a number of assessments (like those we did at screening) to check how well you tolerate the study medicine, and to help us understand how long it takes for your body to process the study medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged between 18 to 40 inclusive.
- You have a Body Mass Index (BMI) within the range of 18.0 and 25.0 kg/m2.
- You must be healthy with no underlying medical conditions that may affect the trial or put you at any significant risk.
- You must not test positive for alcohol or show any evidence of alcohol abuse for 12 months prior to dosing.
- You must not test positive for drugs or show any evidence of drug abuse 12 months prior to dosing.
- You must not use prescription drugs (or herbal or homeopathic preparations) within 14 days prior to screening, with the exception of hormone replacement therapy and contraceptives (birth control).
- You must not receive blood or blood products within 90 days before administration of the study drug.
- You must not donate or plan to donate more than 500 mL of blood within 90 days before administration of study drug and after follow-up is completed.
- You must not have a history of multiple drug allergies.
- You must not have a history of intolerance to injection under the skin (s) or significant abdominal scarring.
- You must not be a smoker or a user of nicotine products, such as vape or nicotine gum.
- Female participants of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting at least one complete menstrual cycle before the first dose until all safety follow-up visits (if applicable) are completed.
- Male participants, if heterosexually active, must agree to the use of acceptable contraception starting from the first dose until all safety follow-up visits (if applicable) are completed.
- Female participants must not be pregnant or breastfeeding or planning to become pregnant or breastfeeding.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £4,286 (£3,286 clinical trial payment and £1,000 bonus), provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Admission: 12th December
Dismissal: 17th December
Follow-up visit(s): 21st, 28th December (2023), 4th, 11th, 25th January, 8th February, 12th March, 10th June, 8th September, and 7th December (2024)
The contents of this email have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C22020_OCT_2022 (email_website_advert text)