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Trial Code
We are conducting a clinical trial for a study drug that could be used to treat patients with Familial Hypercholesterolemia, or FH.
In this clinical trial, we are asking male and female participants aged 18 to 65 years to take part in testing a potential new medicine, so we can see how your body deals with the medicine and how long it stays in your body.
Clinical trial summary
- The intention of the study drug is to target and reduce the activities of a gene made in the liver in order to lower the amount of ‘bad’ cholesterol in the body.
- The aim of the clinical trial is to evaluate the safety of the study drug when given to patients with Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD) and uncontrolled hypercholesterolemia.
- The trial also aims to look at how the study drug will be absorbed, broken down and excreted (pharmacokinetics) from the body.
- This clinical trial will involve you staying at our clinical facility based in London Bridge (see below).
This clinical trial will be divided into three parts:
- Part A: During this part of the study, different dose levels of the study drug will be tested. This study part will consist of four groups which will involve about 3-6 participants per group. Each participant will receive a single dose.
- Part B: This group will receive a single dose of the study drug that was tested in Part A.
- Part C: This optional group will involve participants from Part A who have shown a limited or no response to the study drug (non-responders) after the day 90 visit and who have received a dose of the study drug less than the dose selected for Part B participants. Participants wishing to enter Part C will undergo the Part C Screening visit(s) to confirm they are eligible for Part C. Participants in this group will receive a second dose of the study drug to potentially achieve a medically beneficial response.
- During your in-house stays, you will receive standard meals each day, including breakfast, lunch, evening meals and snacks, served at specific times. You will have to consume all your meals and snacks.
If you are interested in participating in the trial:
- To be considered for the trial, you will first 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 perform a number of tests, including taking blood samples, checking your heart and carrying out a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- If you do decide to take part, the trial would involve:
- A stay of 5 days/4 nights in our clinical facility based in Central London.
- Receiving a dose of the study drug through an intravenous infusion (this means that the drug will be administered into the veins). We will conduct a number of assessments (like those we did at screening) to check how well you tolerate the study drug, and to help us understand how long it takes for your body to get rid of the study drug.
- After your stay with us, you will be required to return for 9 follow-up visits over the year, ending with a final day 365 study visit.
- In total, if you are included in the clinical trial, you will come to the research unit 11 times.
- After the End of Study visit, participants will be asked to participate in a separate long-term follow-up study, which will help monitor participants' safety for a total of 15 years after the date of the first administration of the study drug.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You must be male or female between 18 and 65 years of age.
- You must be diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH) and Atherosclerotic Cardiovascular Disease (ASCVD).
- Your cholesterol medication must include a statin (if not, you will need to have a history of not tolerating these medicines).
- Your cholesterol medication cannot include a PCSK9 inhibitor (such as alirocumab, evolocumab, or inclisiran).
- You must be on stable doses of your cholesterol medication for 30 days prior to screening.
- Have a body mass index (BMI) greater than or equal to 18 kg/m2 and body weight between 45kg and 100kg.
- Male participants must be either surgically sterile or must agree to using condoms and refrain from donating sperm for 90 days after the study drug administration.
- Female participants must be post-menopausal or surgically sterile.
- You must not actively use tobacco products.
- Not have a history of alcohol abuse or heavy consumption of alcohol (defined as an average weekly intake of >21 units for males or >14 units for females).
- You must be willing to participate in a long-term follow-up study for a total of 15 years after the first administration of the study drug.
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 £3,356 (£2,237 clinical trial payment and £1,119 bonus), provided you comply fully with all the clinical trial requirements. This amount is based on the number of visits you have to attend and the time you commit to the study.
Clinical trial dates
Call us on 0207 042 5800 to speak to a member of the team regarding trial dates.
Admission: TBC
Dismissal: TBC
Follow-up appointment(s): TBC
Approval
The contents of this page 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: C21024_SEP_2022
