RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IA-14069 IN HEALTHY SUBJECTS, WITH AN EXTENSION TO EXPLORE ANY DRUG-DRUG INTERACTION POTENTIAL WITH METHOTREXATE (PART 1), AND IN PATIENTS WITH RHEUMATOID ARTHRITIS, WITH PRELIMINARY ASSESSMENT OF EFFICACY IN PATIENTS (PART 2)
This research is looking at a new medicine called IA-14069. It's designed to help people with rheumatoid arthritis, a condition that causes painful, swollen joints. The study has two main parts. In the first part, healthy volunteers will receive different doses of the medicine to see if it's safe, how their body handles it, and if it affects other common medicines like methotrexate. In the second part, people who have rheumatoid arthritis will take IA-14069. The researchers will be checking its safety and looking for early signs that it might help improve their symptoms. This is an early-stage study, meaning it's one of the first times this medicine is being tested in humans.
At a glance
What is this study about?
This study is about a new medicine called IA-14069, which researchers hope could help people living with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition where the body's immune system mistakenly attacks its own joints, leading to pain, swelling, and stiffness.
The study has a few important goals. Firstly, it wants to find out if IA-14069 is safe when given to people. This is always the most important first step for any new medicine. Researchers will also figure out how the body uses and gets rid of the medicine. In one part, they'll check if IA-14069 reacts with another common medicine called methotrexate, which is often used for rheumatoid arthritis. This is important to ensure patients can take both medicines safely if needed.
Finally, in the second part of the study, people who actually have rheumatoid arthritis will be given IA-14069. The main aim here is still to monitor safety, but researchers will also start to look for early signs that the medicine might be effective in reducing symptoms of rheumatoid arthritis. This is a very early stage of research, like the first steps a new medicine takes towards potentially becoming an approved treatment.
Key takeaways
- This study is for a new medicine (IA-14069) for rheumatoid arthritis.
- It first checks the medicine's safety and how it works in healthy people.
- It then looks at safety and early signs of benefit in people with rheumatoid arthritis.
- You might receive the new medicine or a dummy pill (placebo) without knowing which.
- Taking part means regular clinic visits for check-ups and tests.
- You can stop participating at any time.
Who may be eligible?
This study is open to both healthy volunteers and people who have rheumatoid arthritis.
To be considered, you must be at least 18 years old. People of any gender can take part. Specific details about your health, any other medicines you take, and the severity of your rheumatoid arthritis (if you have it) will be checked by the study staff to make sure the study is a good fit for you and safe for you to participate.
They will make sure you meet all the necessary health requirements to take part in this specific research. This helps protect your safety and ensures the study results are as accurate as possible. They will go through a full list of things that might mean you can't join, just like with any clinical study.
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 at least 18 years old?
- Are you currently diagnosed with rheumatoid arthritis (if joining that part of the study)?
- Are you generally healthy (if joining the healthy volunteer part of the study)?
- Are you able to attend regular clinic visits?
- Are you comfortable with blood tests and physical examinations?
What does participation involve?
Taking part in this study would involve several visits to a clinic. You would receive the study medicine, IA-14069, or a 'dummy' medicine (placebo) if you're in the healthy volunteer group – you wouldn't know which one you're getting. During these visits, the study team would regularly check your health, which might include blood tests, urine tests, physical check-ups, and asking about any side effects you might be feeling. If you have rheumatoid arthritis, they would also assess your symptoms to see if the medicine is making any difference. There would be a follow-up period after your last dose to ensure your continued well-being. The total duration of your involvement, including all visits and follow-up, would be explained fully before you decide to join.
Potential risks and benefits
Locations (1)
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Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a condition where your body's immune system attacks your own joints, causing pain, swelling, and stiffness.
What does 'double-blind' mean?
Double-blind means that neither you nor the study doctors will know if you're receiving the new medicine or a dummy medicine (placebo). This helps make the study fair.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects.
Is this medicine available to the public yet?
No, IA-14069 is a new medicine being tested in a clinical trial. It is not yet available for doctors to prescribe.
Do I have to pay to take part?
No, you do not have to pay to take part in this clinical study. Any study-related care and medicines will be provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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