25-011 - A study of a new investigational medicine for PBC
Currently Recruiting
24 Nov 2026
£3,000 - £4,000
London, United Kingdom
A research study of an experimental new medicine for treating primary biliary cholangitis (PBC).
Join our clinical trial
ALN-4285 is designed to help reduce the buildup of bile acids in the liver.
Bile acids are made by the liver and help the body digest fats from food. In people with primary biliary cholangitis (PBC), bile acids can build up in the liver and cause irritation and damage over time.
The study works by reducing the amount of a protein made by the liver, which changes how bile acids are produced. This may help reduce bile acid buildup and protect the liver from damage.
Why participate?
Although there are treatments available for PBC, they do not work well for everyone. Some people continue to experience liver damage or troublesome symptoms despite treatment. Researchers are therefore developing new medicines that work in different ways and may provide additional benefits for people whose disease is not adequately controlled with current therapies.
We are conducting this study to test the safety of the study drug and to find out what effects, if any, it has on healthy adult volunteers. The effects we are studying include:
- Do single doses of the study drug have any important side effects when taken by injection in the skin
- How much of the drug and its breakdown products get into the bloodstream and how long does the body take to get rid of them
- How does the study drug affect the levels of ‘bile acid’ in blood, urine and stool, and
- How does the immune system react to it
Trial details
Delivery method
You will receive a single dose of the study medication administered by injection under your skin, usually into the abdomen (avoiding the area around the belly button), thigh, or the side or back of the upper arms.
Schedule
The study is currently ongoing. Our study team will work with you to arrange trial dates that are convenient and suitable for your schedule.
- You will have a screening visit within 4 weeks before you take the study medication to check if you are suitable.
- You will stay on the ward for 4 days and 3 nights in a row. Then you will leave the ward.
- You will make at least 5 outpatient visits in the 3 months after your dose.
- We will let you then if you were on placebo or if you received the study medicine.
- If you receive the study medicine, you will attend 1 additional outpatient safety visit 6 months after your dose. If you receive placebo, you will not need this extra visit, and your participation will end 3 months after your dose.
Inclusion criteria
You must:
- Be healthy and aged18 to 65
- Have a BMI of 18 to 30
- Be willing to use contraception if there is any possibility that you might become pregnant
- Be willing to stop smoking/vaping while on the ward if you are a smoker/vaper
Exclusion criteria
You must not:
- Be pregnant or breastfeeding
- Have participated in a trial of a small interfering RNA (siRNA) or an oligonucleotide in the last 6 months
Are you a match?
Age
18 - 65 years old
Study payment
£3,000 - £4,000
Gender
Male or Female
BMI
BMI 18 - 30 kg/m2
Commitment
3 nights, 5 or 6 outpatient visits