A double-blind, randomized, placebo-controlled, dose-escalating Phase I trial to determine the safety, pharmacokinetic parameters, and clinical effects of single subcutaneous injections of IGX12 in healthy female and male participants
This research study is about a new medicine called IGX12. It's the very first time this medicine is being given to people, specifically healthy men and women. The main goals are to check if single injections of IGX12 are safe and well-tolerated. Researchers also want to understand how the body processes the medicine, for example, how much of it stays in the body and for how long. They will also look for any initial effects the medicine might have. This type of early-stage study is crucial for developing new treatments for conditions like infertility, helping scientists learn if a new medicine works in the way they expect before it's tested in people who are unwell. This trial is an important step towards potentially finding new ways to help people struggling with fertility issues.
At a glance
What is this study about?
This study is a very early step in testing a new medicine called IGX12. Think of it like a first test drive for a new car – we're not asking it to win a race yet, but just checking that it starts, stops, and is safe to drive. In this case, doctors want to make sure that IGX12 is safe for people. They will be giving single injections of the medicine to healthy men and women.
Because this is the very first time IGX12 is being used in people, the main focus is on safety. The research team will be carefully watching for any side effects. They will also be looking at how the body handles the medicine – for example, how much of it gets absorbed, how long it stays in the body, and how it's eventually removed. This information is really important because it helps scientists work out the best dose to use in future studies.
Even though this study is in healthy volunteers, the long-term goal is to see if IGX12 could eventually help people who are experiencing infertility. By understanding the medicine's safety and how the body handles it now, researchers can decide if it's promising enough to be tested in people with infertility later on. This is a vital stage in bringing new treatments from the lab to patients.
Key takeaways
- This is an early study of a new medicine (IGX12) for potential infertility treatment.
- It's the first time this medicine is being given to healthy people.
- The main aims are to check safety, how the body handles the medicine, and initial effects.
- Both healthy men and women aged 18 and over can potentially take part.
- Participants will receive single injections of either IGX12 or a dummy medicine (placebo).
- Taking part helps advance medical knowledge and could lead to new future treatments.
Who may be eligible?
This study is looking for healthy adult volunteers. If you are 18 years old or older, you might be able to take part. Both men and women are welcome.
The study involves healthy people, meaning you shouldn't have any significant ongoing medical conditions. This helps the researchers understand the effects of the new medicine without other health issues making it difficult to tell what's happening.
There will be other specific things the doctors need to check – for example, certain blood test results or whether you're taking particular medicines already – to make sure it's safe for you to join. These details will be explained fully by the study team.
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?
- Are you willing to receive single injections?
- Are you able to attend several clinic visits for health checks?
- Are you comfortable with the possibility of receiving a dummy injection (placebo)?
What does participation involve?
If you decide to take part, you would receive single injections of the study medicine, IGX12, or a placebo (a dummy injection that looks the same but contains no active medicine). You wouldn't know which one you received, nor would the doctors, to keep the results fair. This is called 'double-blind'.
There will be several visits to the clinic, both before you receive the injection and afterwards, to monitor your health. These visits will involve health checks like blood pressure, heart rate, and blood tests to see how your body is reacting and processing the medicine. The total time you would be involved in the study, from your first visit to your final check-up, would be fully explained by the research team.
Potential risks and benefits
Locations (1)
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Common questions
What is infertility?
Infertility means not being able to get pregnant after regular unprotected sex for a certain period. It can affect men and women.
What does 'Phase I' mean?
Phase I is the very first stage of testing a new medicine in people. It mainly focuses on safety and understanding how the medicine works in the body.
What is a 'placebo'?
A placebo is a 'dummy' treatment, like a sugar pill or a saline injection, that looks exactly like the real medicine but contains no active ingredients. It helps researchers fairly compare the effects of the new medicine.
Will I know if I'm getting the real medicine or the placebo?
Neither you nor the study doctors will know whether you're receiving the active medicine (IGX12) or the placebo during the study. This is called 'double-blind' and helps ensure the results are accurate.
Do I have to pay to join the study?
No, you will not have to pay to be part of the study. All study-related assessments and medicines are provided free of charge.
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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