AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pimozide after Multiple Dose Administration in Subjects with Rheumatoid Arthritis

This research study is investigating a new medicine called Pimozide for people with rheumatoid arthritis. The main goals are to understand if the medicine is safe when given several times, what side effects people might experience, and how the body handles the medicine and reacts to it. This is a 'Phase 1' study, which means it’s one of the first times this medicine is being tested in people. Participants will receive either the study medicine or a placebo (a dummy pill with no active drug) to help researchers compare the effects accurately. The results will help determine if this medicine should be studied further for rheumatoid arthritis. We are looking for adults of all genders to take part in this important research.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Generos Biopharma Ltd.

Enrolment target

Start

20 Nov 2023

rheumatoid arthritis

What is this study about?

This research project is looking into a new medicine called Pimozide, which might help people with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. Developing new treatments is really important to improve the quality of life for those living with this condition.

In this study, researchers want to answer some key questions about Pimozide. Firstly, they want to make sure it's safe to use and understand any side effects it might cause, especially when people take it more than once. Secondly, they want to see how the body processes the medicine – how it's absorbed, distributed, used, and removed. They also want to understand the effects of the medicine on the body.

This is a very early stage study, often called a 'Phase 1' study. This means it's one of the first times this specific medicine is being given to people. The main focus at this stage is always safety. The information gathered from this study will help decide if Pimozide has the potential to be a useful treatment for rheumatoid arthritis and if it's safe enough to move on to larger studies.

Key takeaways

This study is testing a new medicine called Pimozide for rheumatoid arthritis.
It's a very early-stage study (Phase 1) focused on checking safety and how the medicine works.
Participants will randomly receive either the new medicine or a dummy pill (placebo).
It's open to adults aged 18 and over, of all genders.
Your health will be closely monitored by doctors and nurses.
You can stop taking part at any time without any problems.

Who may be eligible?

To be able to join this study, you must be an adult aged 18 years or older. The study is open to both men and women.

Beyond your age and gender, there will be other important health requirements to make sure the study is safe for you and that the results are clear. For example, you would need to have a confirmed diagnosis of rheumatoid arthritis. The research team will review your full medical history and current health to determine if you are a good fit for this particular study.

It's important to know that certain health conditions or medications you are currently taking might mean you can't join the study, even if you have rheumatoid arthritis. This is normal for research studies to protect your safety and ensure the study's findings are reliable.

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 a diagnosis of rheumatoid arthritis?
Are you able to attend regular clinic visits?
Are you willing to potentially receive either the study medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medicine (Pimozide) or a placebo, which looks exactly like the study medicine but contains no active drug. This is done randomly, like flipping a coin, and neither you nor the study team will know which you are receiving – this is called 'double-blind'.

You will need to attend several visits to the clinic over a number of weeks. During these visits, the study team will carry out various assessments. These could include blood tests, urine tests, physical check-ups, and asking you questions about your health and any side effects you might be experiencing. These tests help ensure your safety and show how the medicine is working in your body. There will also be follow-up appointments after you stop taking the medicine to make sure you are well. The total duration of your involvement, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study might offer some potential benefits, such as gaining access to a new experimental medicine before it's widely available. Your health will also be closely monitored by medical professionals throughout the study. However, there are potential risks, as there could be side effects from the study medicine, some of which may be unknown at this early stage. You will be fully informed of all known potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Bulgaria

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first step in testing a new medicine in people. It mainly focuses on checking if the medicine is safe and what side effects it might cause.

What does 'placebo-controlled' mean?

This means some people will get the active medicine, and others will get a 'dummy' pill (a placebo) that looks the same but has no medicine. This helps researchers compare the real effects of the drug.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting the active medicine and who is getting the placebo until the study is over.

Why is it important to test new medicines for rheumatoid arthritis?

New medicines are needed to give people more options for managing their symptoms, reducing joint damage, and improving their quality of life with rheumatoid arthritis.

Can I stop participating in the study if I change my mind?

Absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it won't affect your regular medical care.