A Phase 1 study to evaluate the effect of BV100 on the pharmacokinetics of polymyxin B in healthy volunteers
Certain hospital bugs, such as a bacterium called Acinetobacter baumannii, are becoming resistant to standard antibiotics. This makes infections difficult to treat. Doctors are testing a new experimental medicine named BV100 to see if it can help. This Phase 1 study looks at what happens when healthy volunteers take BV100 together with polymyxin B, an antibiotic already in use. Researchers want to understand how the body processes these medicines together, checking if one drug alters the levels of the other in the bloodstream. Because this is an early safety and pharmacology study, participants must be generally healthy. Taking part involves health checks and regular blood samples so doctors can measure drug levels. While volunteers will not gain direct health benefits, their participation helps scientists design safer, more effective treatments for people facing severe bacterial infections in the future.
At a glance
What is this study about?
Antibiotics are vital medicines that fight bacterial infections. However, some bacteria are learning to survive these treatments, a problem known as antibiotic resistance. One particularly tough bacterium is called Acinetobacter baumannii, which often causes serious chest and bloodstream infections in hospital patients. Because standard treatments often fail against this bug, scientists are working on new medicines to fight back.
This study is testing an experimental medicine called BV100. Researchers are combining it with polymyxin B, an established antibiotic often used as a last resort against resistant bacteria. The main aim is to understand the 'pharmacokinetics' of the drugs—which simply means looking at how the body absorbs, breaks down, and clears them. Scientists need to confirm that taking both medicines together does not cause unexpected changes in drug levels in the blood.
Because this is a Phase 1 clinical trial, it focuses on safety and how the drugs behave rather than treating an active illness. That is why doctors are inviting healthy volunteers to take part. The knowledge gained from this trial will help researchers decide the correct doses to use in future studies with patients who are seriously ill with bacterial infections.
Key takeaways
- Tests how a new medicine (BV100) and an antibiotic (polymyxin B) behave together in the body.
- Open to healthy adult volunteers aged 18 and over.
- Helps develop new treatments for antibiotic-resistant hospital infections.
- Involves detailed health monitoring and frequent blood tests at a research clinic.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is looking for healthy adult volunteers aged 18 and older. Both men and women are welcome to apply.
To join, you must be in good general health, with no major ongoing medical conditions. The study team will check your medical history and run standard health tests to confirm that it is safe for you to take part.
You might not be able to join if you have certain chronic illnesses, kidney problems, allergies to antibiotics, or if you are currently taking medications that could interfere with the study results. Pregnant or breastfeeding women are usually excluded from early drug studies for safety reasons.
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.
- I am at least 18 years old.
- I consider myself to be in good general health.
- I do not have serious long-term kidney or liver problems.
- I am not known to be allergic to polymyxin antibiotics.
- I am willing to attend clinic visits and give blood samples for research.
What does participation involve?
If you decide to join the study, you will first attend a screening visit. The medical team will check your blood pressure, take blood and urine samples, and review your medical history to make sure you are suitable to take part. You will also have the chance to ask any questions.
During the study, you will receive doses of the study medicines under close medical supervision. This may require staying at a specialist clinical research unit for a short period, followed by outpatient visits. Throughout your stay, nurses and doctors will take regular blood samples to measure the exact levels of the medicine in your body.
After you finish taking the study drugs, there will be a follow-up check to make sure you are feeling well. The study team will explain the exact schedule, visit lengths, and overall timeline before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedAustria
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the earliest stage of testing a medicine in humans. It focuses on safety, side effects, and how the body handles the drug, usually in a small group of healthy volunteers.
Will I be paid for taking part?
Phase 1 studies with healthy volunteers often provide payment or compensation to cover your time, travel expenses, and inconvenience. The study team can give you specific details.
Do I need to have a bacterial infection to join?
No. This trial is specifically designed for healthy volunteers who do not have an active infection.
Why are blood tests taken so often?
Frequent blood samples allow researchers to map out how quickly the medicine enters the blood, reaches its highest level, and leaves the body over time.
Can I leave the study early if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, without it affecting your regular NHS medical care.
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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