A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants.
This research is an early-stage study for a new medicine called LY3876602. It's designed for healthy adults and is the very first time this drug will be given to people. The main goals are to check if the medicine is safe, to understand what dose people can comfortably take, and to see how the body processes it. Participants will receive either the new medicine or a dummy pill (placebo) without knowing which one they have. This helps us get clearer results. We'll be looking closely at any side effects and how the medicine works inside the body after single and repeated doses. This information is key for deciding if the medicine should be studied further.
At a glance
What is this study about?
This study, called a Phase 1 study, is the very first time a new medicine named LY3876602 will be given to people. Think of it as a first test flight for a new plane – we need to make sure it's safe to take off before we invite passengers on board. We’re inviting healthy volunteers, which means people who don’t have any known health problems.
The main things we want to find out are: is this new medicine safe? What dose can people take without too many problems? And once it’s in the body, how does it move around and how long does it stay there? This helps us understand if it has the potential to be a useful treatment in the future. We're not testing it for a particular illness yet, just seeing how a healthy body reacts to it.
To make sure our results are as clear as possible, this study is 'double-blinded' and includes a 'placebo'. This means neither you nor the study team will know if you're getting the actual medicine or a dummy pill. This prevents anyone's expectations from influencing the results. We’ll carefully watch all participants for any changes or side effects, and take various measurements to understand the medicine's journey through the body.
Key takeaways
- This is a first-time test of a new medicine in healthy people.
- The main goals are to check safety, how much the body can handle, and how the medicine moves through the body.
- You might receive the new medicine or a dummy pill (placebo); neither you nor the doctors will know which.
- Participants must be healthy adults, aged 18 or older.
- Participation involves clinic visits, possibly overnight stays, and various health checks.
- You can stop participating at any time.
Who may be eligible?
This study is looking for healthy adults to take part. This means we are seeking people who feel well, don't have any serious ongoing health conditions, and aren't taking regular medications that might interfere with the study drug.
To be eligible, you need to be at least 18 years old. There is no upper age limit, so adults of all ages, as long as they are healthy, can consider participating. Both men and women are welcome to join this study.
Before you can take part, the study team will do some health checks to make sure you truly are healthy enough for the study. They will explain what 'healthy' means in more detail for this particular research.
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.
- Am I at least 18 years old?
- Do I consider myself to be in generally good health?
- Am I able to commit to the study visits and requirements?
- Am I comfortable with the idea of taking a new, untested medicine or a dummy pill?
- Am I not currently pregnant, breastfeeding, or planning to become pregnant during the study?
What does participation involve?
If you decide to take part, you would receive either the new medicine (LY3876602) or a dummy pill (placebo). You won't know which one you're getting, nor will the study team. You'll have several visits to the study clinic, likely starting with a stay of a few days to receive the first doses and have close monitoring. After this, you might have further short stays or outpatient visits to receive more doses (if you're in the part of the study looking at multiple doses) and for follow-up health checks.
During your visits, various assessments will be done, such as blood tests, urine tests, checking your heart rate and blood pressure, and potentially other examinations to understand how the medicine is affecting your body. The total duration of your participation, including all visits and follow-up, will be explained to you by the study team before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What does 'Phase 1 Study' mean?
It means this is the first time a new medicine is given to people, mainly to check its safety and how the body handles it.
What does 'double-blinded' mean?
It means neither you nor the study team will know if you're getting the active medicine or a dummy pill (placebo) until after the study is over.
Why is a dummy pill (placebo) used?
It helps us compare the effects of the new medicine more accurately, ensuring any changes we see are truly due to the medicine and not just expectation.
Will I get paid for taking part?
You might be compensated for your time and travel, but this will be fully explained by the study team before you join.
What if I feel unwell during the study?
The study team will monitor you closely, and you should tell them immediately if you feel unwell. Your safety is their top priority.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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