A Participant- and Investigator--Blinded, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants with Chronic Kidney Disease
This research study is looking at a new medicine called OJR520. It's being tested for the first time in people, including healthy volunteers and individuals who have chronic kidney disease. The main aims are to understand how safe the medicine is, how well people tolerate it, and how the body processes it. Researchers also want to see if it has any specific effects on the body. To make sure the results are fair, neither the participants nor the doctors giving the treatment will know who is getting the actual medicine and who is getting a placebo (a dummy treatment). This helps ensure that any observed changes are truly due to the medicine being tested.
At a glance
What is this study about?
This research study is about a new potential medicine called OJR520. It's being investigated for people living with chronic kidney disease, which means their kidneys aren't working as well as they should. The study is also open to healthy adult volunteers who do not have kidney problems.
The main purpose of this early-stage study is to carefully check if OJR520 is safe for people to take and if their bodies can tolerate it without too many unwanted side effects. Researchers will also learn how the medicine moves through and is processed by the body, and if it has any effects on the body's systems. Knowing this information is crucial before the medicine can be tested in larger groups of people.
To ensure the results are reliable, this study is designed in a special way. Participants will be randomly assigned to either receive the new medicine or a 'placebo' – which looks like the medicine but contains no active ingredient. Neither the participants nor the research team will know who is getting which, making it a 'blinded' study. This helps prevent any bias when observing the effects of the medicine. This is a very common and important step in developing new treatments.
Key takeaways
- This is an early study of a new medicine for chronic kidney disease.
- It's mainly checking how safe the medicine is and how the body handles it.
- Both healthy volunteers and people with kidney disease can take part.
- Participants will randomly receive either the new medicine or a dummy treatment (placebo).
- Your health will be closely monitored by medical staff throughout the study.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part. The study is particularly looking for two groups of people: healthy volunteers who don't have chronic kidney disease, and individuals who have been diagnosed with chronic kidney disease.
There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the age and sex criteria. For example, certain other medical conditions or taking particular medications could make someone ineligible. These rules are put in place to keep participants safe and to make sure the study results are clear.
It's important to talk to the study team or your own doctor to find out all the detailed requirements. They can explain if your medical history makes you a good fit 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.
- Are you 18 years old or older?
- Do you have chronic kidney disease, or are you a healthy adult?
- Are you generally able to attend regular clinic visits?
- Are you able to follow study instructions carefully?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, OJR520, or a placebo (a dummy treatment). You would have regular visits to the study clinic, where doctors and nurses would carefully check your health. This would involve things like blood tests, urine tests, and checking your vital signs (like blood pressure and heart rate).
During these visits, you'd also be asked questions about how you're feeling and any changes you notice. The study involves different groups of participants receiving varying doses of the medicine over a period of time, followed by a time when no medicine is given so researchers can see how your body gets rid of it. The total duration of your participation would be explained in full detail by the study team, but typically, these early-stage studies can last several weeks to a few months.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedRomania
Common questions
What is a 'placebo'?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine accurately.
Why don't I know if I'm getting the real medicine or the placebo?
This is called a 'blinded' study. It helps prevent anyone's expectations (yours or the doctors') from influencing the results, making the study fairer and more reliable.
What does 'Phase I' mean?
Phase I is the first time a new medicine is given to people. It mainly focuses on safety, how the body handles the medicine, and finding a suitable dose.
Will I get paid to participate?
Some studies offer payment for your time and travel, but this varies. The study team will tell you if any compensation is available.
Can I stop participating if I want to?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.