A study to compare how the body takes in and gets rid of sefaxersen when given by an injection device or a regular syringe in healthy adults
This research is investigating a drug called sefaxersen, which is being developed as a potential new treatment for a kidney disease called primary IgA nephropathy. Currently, this drug is given as an injection under the skin using a standard syringe. This study aims to test a new injection device to see if it delivers the drug just as effectively and safely as the current syringe method, but is easier to use. We need healthy volunteers to take part. The main goal is to check how quickly and how much of the drug gets into the bloodstream with each method. We will also carefully monitor any side effects. This early-stage study helps us understand the drug and device in healthy people before it's tested in those with the kidney condition.
At a glance
What is this study about?
This study is looking into a drug called sefaxersen. This drug is currently being studied as a possible new treatment for a kidney condition known as primary IgA nephropathy. The drug aims to help reduce damage to the kidneys by targeting harmful substances made in the liver. At the moment, sefaxersen is given as a jab under the skin using a regular syringe.
A new device has been developed to give this injection. The main purpose of this study is to find out if this new device delivers the drug into the body just as well as the standard syringe. We want to see if the new device makes it easier to give the injection. The study will specifically compare how quickly and how much of the drug gets into the bloodstream with both the new device and the regular syringe. This is important to make sure the drug works effectively no matter how it's given.
Because sefaxersen is still in early development, we're asking healthy adult volunteers to take part in this study. This allows researchers to first check that the drug and the new device are safe before they are used in people who are already unwell. It also helps us understand the drug's effects without other health conditions making things more complicated. We will also be carefully checking for any side effects with both ways of giving the drug.
Key takeaways
- Tests a new injection device for a kidney disease drug (sefaxersen).
- Compares the new device to a standard syringe in healthy adults.
- Aims to check if the new device delivers the drug just as well and is easier to use.
- Looks for safety and how the drug behaves in the body.
- Involves a 5-day stay and 6 follow-up visits over 28 weeks.
- Participation helps future patients, but no direct personal benefit.
Who may be eligible?
To take part in this study, you need to be a healthy adult, aged between 18 and 55 years old. Your Body Mass Index (BMI) should be between 18.5 and 32, and your weight should be between 55 and 110 kg.
If you are a woman, you cannot be pregnant or breastfeeding. If you can become pregnant, you must agree to use reliable birth control during the study. If you are a man, there are no specific birth control requirements.
You also need to have had certain vaccinations recently, including against Neisseria meningitidis (within the last 3 years), Streptococcus pneumoniae, and Haemophilus influenzae B, according to standard health guidelines. If you need any of these vaccinations, they must be completed at least two weeks before you receive the study drug.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 55 years old?
- Are you generally healthy?
- Is your weight between 55 kg and 110 kg?
- Have you had recent vaccinations (N. meningitidis, S. pneumoniae, H. influenzae B)?
- If female, are you not pregnant or breastfeeding and willing to use reliable birth control?
- Are you able to stay at a research unit for 5 days and attend 6 follow-up appointments?
What does participation involve?
If you decide to take part, the study will last about 28 weeks. This includes an initial 5-day stay at the research unit. During this stay, you will receive the sefaxersen injection, either with the new device or the standard syringe, as decided by chance. After this, you will have 6 follow-up visits. At these visits, and during your stay, you will have check-ups like physical exams, blood tests, and urine samples. These help the doctors monitor your health and how the drug is affecting your body.
Potential risks and benefits
Locations (1)
- Medicines Unit Evaluation (MEU)City onlyManchester, United Kingdom
Common questions
What is sefaxersen?
Sefaxersen is a drug being developed as a possible new treatment for a kidney disease called primary IgA nephropathy.
Why is this study using healthy volunteers?
Using healthy volunteers in early studies helps researchers confirm the drug and injection method are safe before testing them in people who are already unwell due to a kidney condition.
What is the new injection device for?
The new injection device is being tested to see if it can deliver the sefaxersen drug just as effectively and safely as a regular syringe, but in a way that is easier to use.
Will I get paid for taking part?
The study information provided does not mention payment for participation. It only states there are no direct personal benefits.
What are the biggest risks?
Possible risks include side effects from the drug itself, such as an increased risk of infections or slight changes in your liver readings. There are also minor risks from injections and blood tests.
How to find out more
Sarah Casey
Always speak to your GP or specialist before deciding to take part in a study.
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