A trial to learn if different doses of REGN17092 are safe in healthy adults
This study is an early-stage trial designed to understand if a new unapproved medicine, REGN17092, is safe for healthy adults. Researchers want to find out if different amounts (doses) of this medicine can be given without causing serious side effects. This is the very first time this medicine is being given to people. The study will also start to look at how the body handles the medicine. The main goal is to check its safety, as this is crucial before it can be tested in people who are actually ill with COVID-19. Participants will be closely monitored by a team of doctors and nurses to ensure their well-being throughout the study.
At a glance
What is this study about?
Imagine a new medicine is being developed to help treat COVID-19. Before it can be given to people who are unwell, scientists need to be absolutely sure it's safe. That's what this study is all about. It's called a 'Phase I' trial, which means it's one of the very first times this medicine, named REGN17092, is being given to healthy people.
The main purpose of this study is to carefully check if the medicine is safe when given in different amounts (doses). The researchers will be looking for any side effects and how healthy people react to the treatment. They also want to understand how the medicine moves through and is processed by the body. This helps them work out what might be the best dose to use in future studies.
Taking part in this kind of study won't directly treat COVID-19 because you need to be healthy to join. However, the information learned from healthy volunteers is incredibly important. It helps pave the way for future studies that could eventually lead to new treatments that help people who get seriously ill with COVID-19. Your participation, if you choose to join, would be a vital step in medical research.
Key takeaways
- This is an early study testing the safety of a new medicine for COVID-19.
- It's for healthy adults aged 18 and over, both men and women.
- The main goal is to check how safe the medicine is at different doses.
- Participants will be closely watched by doctors and nurses.
- There are no direct personal health benefits, but it helps future research.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet the health requirements.
Both men and women are welcome to participate. The study team will check your general health very carefully to make sure you are suitable and that it's safe for you to take part.
While the basic requirements are straightforward, the study will have detailed health checks to make sure you are truly healthy and don't have any medical conditions that could make the trial unsafe for you. This ensures the safety of everyone involved.
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 18 years old or older?
- Are you generally healthy and don't have any serious ongoing medical conditions?
- Are you a man or a woman?
- Are you able to attend all required clinic visits and follow-up appointments?
- Are you comfortable with receiving an unproven medicine and having regular medical checks like blood tests?
What does participation involve?
If you decide to take part, you would receive doses of the new medicine, REGN17092. The study team will tell you exactly how many visits you'll need to make to the clinic, which might include overnight stays for close monitoring, especially after receiving the medicine. During these visits, nurses and doctors will carry out various assessments. This includes regular blood tests, urine tests, checking your heart (with an ECG), and keeping an eye on your general health.
You will be given the study medicine and your reaction will be carefully observed. After you leave the clinic, there will be follow-up appointments, which could be in person or over the phone, to continue checking on your health and any long-term effects. The total length of your participation, from start to finish, will be explained fully by the study team, but these types of early trials often involve several weeks or even a few months of monitoring.
Potential risks and benefits
Locations (1)
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Common questions
What is REGN17092?
REGN17092 is a new medicine that is being investigated to see if it could help people with COVID-19. This study is one of the very first times it's being tested in humans.
Will I get paid for taking part?
The study information doesn't state if payment is offered, but often studies like this offer some reimbursement for your time and travel. This is something you should ask the research team directly.
What happens if I feel unwell during the study?
You will be closely monitored by doctors and nurses. If you feel unwell, you should tell the study team immediately, and they will provide care and assess your situation.
Will I catch COVID-19 from the medicine?
No, the medicine is not designed to give you COVID-19. It is being developed as a potential treatment or preventive measure for the virus, not to cause it.
How long will I need to be in the study?
The total time you will be involved in the study, including visits and follow-ups, will be explained by the study team. Early studies like this can often last for several weeks or a few months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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