Phase 1 Study of ADX-626 in Healthy Participants
This study is an important first step in understanding a new medicine called ADX-626. It's designed for healthy adults between 18 and 45 years old and is the first time this medicine will be given to people. The main goal is to check that ADX-626 is safe and that people can tolerate taking it without too many problems. We also want to learn how the medicine behaves inside the body – for example, how much gets into the bloodstream and how long it stays there, and what effects it might have. Participants will either receive ADX-626 or a dummy medicine (placebo). Your involvement will help us understand if this medicine could be useful for future treatments.
At a glance
What is this study about?
This study is called a "Phase 1" trial. This means it's one of the very first times a new medicine, in this case, called ADX-626, is being tested in people. The main reason for doing this first study is to make sure the medicine is safe and to see if healthy volunteers can take it without serious side effects. We also want to understand how the medicine works in the body, such as how it's absorbed and processed.
Because this is the first time ADX-626 is being given to humans, we are looking for healthy adult volunteers. This helps us see the effects of the medicine clearly, without other health conditions getting in the way. Half of the participants will receive ADX-626, and the other half will receive a 'placebo', which looks exactly like the study medicine but contains no active drug. This helps us compare the effects of the actual medicine.
The information we gather from this study is incredibly important. It helps us decide whether ADX-626 is safe enough to be tested in further studies for specific conditions. Your participation could play a vital role in developing new treatments for the future.
Key takeaways
- This is a first-in-human study of a new medicine, ADX-626.
- It aims to check the safety and how ADX-626 works in healthy adults.
- Participants will receive either ADX-626 or a dummy medicine (placebo).
- It's for healthy adults aged 18-45.
- Information from this study helps decide if ADX-626 can be studied further.
- Your participation helps advance medical research.
Who may be eligible?
To be part of this study, you need to be a healthy adult aged between 18 and 45 years old. The study is open to both men and women who are not able to have children (or take steps to prevent pregnancy). You'll need to weigh at least 50 kg (about 7 stone 12 pounds) and have a healthy body mass index (BMI) of 25 or below. We will also check your blood to make sure your liver, blood count, and clotting are normal. If you are female and could become pregnant, you'll need to agree to use a reliable method of contraception during the study.
There are also some reasons why you might not be able to join. For example, if you have a serious medical condition like high blood pressure, diabetes, heart disease, or cancer. You also can't have a history of bleeding problems or a current infection. If you've taken part in another drug study in the last 90 days (about three months), you wouldn't be able to participate in this one. All participants must be willing to follow all the study rules.
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 45 years old?
- Do you consider yourself generally healthy?
- Do you weigh at least 50 kg (approx. 7 stone 12 lbs)?
- Have you *not* participated in another drug study in the last 3 months?
- Do you *not* have any serious ongoing medical conditions like diabetes or heart disease?
- Are you willing to attend regular clinic visits and have blood tests?
What does participation involve?
If you decide to take part, you will be assigned to either receive the study medicine (ADX-626) or a dummy medicine (placebo). You won't know which one you are receiving. The study involves several visits to the clinic, where doctors and nurses will monitor your health closely. This will include regular blood tests to check how the medicine is affecting your body and to track its safety. You might also have other assessments to check your general health.
The specific number of visits and their duration will be explained in full detail. You'll be given the study medicine, and we'll ask you to report any changes in how you feel. There will be a follow-up period after you stop taking the medicine to ensure you remain well. The total time you'll be involved in the study will be clearly explained before you agree to take part.
Potential risks and benefits
Locations (1)
- Richmond PharmacologyVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is a 'Phase 1' study?
A Phase 1 study is the first step where a new medicine is given to people. Its main goal is to check for safety and find out how much of the medicine the body can handle without serious problems.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the study medicine but doesn't contain any active drug. Giving a placebo helps us truly understand the effects of the actual medicine.
Will I know if I'm getting the active medicine or the placebo?
No, during the study, neither you nor the study team will know whether you are receiving ADX-626 or the placebo. This is to ensure the results are as fair and accurate as possible.
How long will I need to be involved in the study?
The total duration of your participation, including clinic visits and follow-up, will be fully explained by the study team before you decide to join.
Will I get paid for taking part?
Information about any payment or reimbursement for travel and expenses will be provided by the study team.
How to find out more
Nali Castillo
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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