Trial Code
C24049
Ages
18+
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
N/A
Nicotine Restrictions
Nicotine users allowed
Duration of stay
3 days / 2 nights
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What does participation involve?
If you are interested in participating in the study:
- You will need to attend a screening appointment so we can check if you are suitable to take part in the study. At this appointment, we will take blood samples, check your heart function and carry out a physical examination, among other assessments. The screening period is up to 6 weeks. If you participate in the sub-study, the screening period could be extended to 12 weeks.
- If the results from your screening appointment show that you are suitable for the study, you will be invited to take part. You will be admitted to the study location on Day-1. On Day 1, you will receive either the study drug or a placebo (dummy treatment) through infusion. This will involve an in-house stay of 3 days /2 nights at the study location.
- For subsequent dosing, you will attend the study location for visits every 4 weeks to receive the infusion into the vein and undergo various tests and procedures. The number of visits will depend on the number of times you receive the study drug.
- When your study treatment ends, you will have End of Treatment (EoT) and End of Study (EOS) tests and procedures at the study site. The EoT Visit will take place 4 weeks after your last study treatment infusion, and the EoS Visit will take place 12 weeks after the EoT Visit.
The estimated study duration is anticipated to range from 23 to 48 months. During your treatment period, you will receive a single dose of the investigational drug or placebo by infusion. We will conduct a number of assessments (like those we did at screening) to check how well you tolerate the investigational drug.
Who can take part?
We will check your suitability for the clinical study using the following key criteria:
- You are at least 18 years old.
- You have been diagnosed with a heart condition caused by changes in the transthyretin (TTR) protein, called variant or wild-type TTR amyloid cardiomyopathy (ATTRv-CM or ATTRwt-CM).
- Have experienced heart failure and are currently receiving ongoing treatment for your heart condition.
- You must be healthy with no underlying medical conditions that may affect the study or put you at significant risk.
- You must not be currently participating or have previously participated (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
- You must not be pregnant or breastfeeding or planning to become pregnant.
- Female participants of childbearing potential: You must be on a highly effective method of contraception for at least 16 weeks after the study treatment administration.
A full list of do's and dont's will be given to you by a member of our recruitement team if you are interested.
Payment information
Please note that you will not receive any payment for taking part in this research study.
If you would like to speak to a member of our Volunteer Recruitment Team, call us on 020 7042 5802
Register for this clinical trial
