This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of BEAM-103 in Healthy Subjects
This research study is looking for healthy volunteers aged 18 to 55 to test a new medicine called BEAM-103. It's a 'Phase 1' study, which is the very first step in checking if a new medicine is safe for people. We want to understand how your body reacts to BEAM-103, how much of it stays in your system, and if it causes any changes, especially to your blood. Some volunteers will receive BEAM-103, and others will get a placebo (a dummy medicine) – but neither you nor the research team will know who gets what. This helps us get clearer results. The information gathered will help us decide the best dose to use for future studies in patients.
At a glance
What is this study about?
This study is a crucial first step in developing a new medicine called BEAM-103. Imagine it like a thorough check-up for a brand-new car model before it goes out on the road. In this case, we're not testing a car, but a potential new treatment. Right now, we're focusing on understanding BEAM-103 in healthy people, rather than patients with a specific illness. This allows us to see how it works generally without the added complications of an existing health condition.
The main goals of this study are to make sure BEAM-103 is safe and well-tolerated by the body. We also want to learn how your body processes the medicine, how long it stays in your system, and what effects it might have, particularly on your blood. Understanding these early details helps us work out the right dose for future testing. It's a bit like finding the 'sweet spot' for the medicine, where it could be most effective with the fewest side effects.
By carefully observing how healthy volunteers respond, we can gather vital information that will guide further research. This includes choosing the best dose for future studies that might involve patients who could potentially benefit from BEAM-103. Your participation in this early stage is incredibly valuable, as it paves the way for potential new treatments down the line.
Key takeaways
- This is a first-stage study testing a new medicine (BEAM-103) for safety.
- It involves healthy volunteers (ages 18-55) in the UK.
- You'll receive either the new medicine or a placebo, and neither you nor the staff will know which.
- The study lasts about 4-5 months, with one infusion and follow-up visits.
- Your participation helps gather crucial information for future potential treatments.
- It's voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, we're looking for healthy adults between 18 and 55 years old. Your overall health is important, and we'll check this with a physical exam, heart tracing (ECG), and blood tests to make sure everything is in good working order. We also need your Body Mass Index (BMI) to be within a specific range, and your blood counts (like neutrophils, haemoglobin, and platelets) need to be at healthy levels.
There are also some reasons why you wouldn't be able to join. For example, if you're allergic to any of the ingredients in the study medicine, or if you've recently taken part in another research study involving an experimental treatment. For women, if you are pregnant or breastfeeding, you won't be able to take part. Also, if you've had certain vaccinations recently or have any severe ongoing medical conditions (like severe asthma or a serious peanut allergy) that the doctors think could put you at risk or make it hard to understand the study results, you might not be eligible. Our aim is to ensure your safety throughout the study.
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?
- Do you consider yourself generally healthy?
- Do you have a healthy Body Mass Index (BMI)?
- Are you not currently pregnant or breastfeeding (if applicable)?
- Have you avoided other experimental treatments in the last 3 months?
- Do you have no severe, uncontrolled medical conditions or known allergies to study components?
What does participation involve?
If you decide to take part, you'll first be asked to read and sign a consent form, making sure you understand everything about the study. We'll then check if you meet all the eligibility criteria, followed by a review of your medical and medication history. You'll receive a single dose of either BEAM-103 or a placebo (a dummy treatment) directly into your vein on 'Day 1' of the study. You won't know which one you're getting, and neither will the study staff; this is to ensure the results are as unbiased as possible. After this, you'll have follow-up visits and assessments for about 4 months to see how you're doing. The total time you'd be involved in the study, from start to finish, would be between 4 and 5 months.
Potential risks and benefits
Locations (1)
- Clinical Study SiteVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is a 'Phase 1' study?
Phase 1 is the very first step in testing a new medicine in people. It mainly focuses on safety and how the body handles the medicine, usually in healthy volunteers.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the actual medicine but doesn't contain any active ingredients. It helps researchers compare the effects of the new medicine.
What does 'single-blind' mean?
In this study, 'single-blind' means that you, as a participant, won't know if you're receiving the actual medicine (BEAM-103) or the placebo. This helps prevent bias in how you report how you feel.
Will I get paid for participating?
The information provided doesn't specify if payment will be offered. This is something you should ask the research team directly if you're interested in participating.
What are 'pharmacokinetics' and 'pharmacodynamics'?
Pharmacokinetics looks at what the body does to the medicine (how it's absorbed, distributed, broken down, and removed). Pharmacodynamics looks at what the medicine does to the body (its effects and how it changes things).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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