AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A First-in-Human, Open-label, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of NBIM-1008 in Patients with Rheumatoid Arthritis

This is a very early, open-label study (meaning everyone knows what treatment they're getting) called a Phase 1 trial. We're looking for volunteers with rheumatoid arthritis to test a new medication, NBIM-1008. The main goals are to check if the medicine is safe, how well people tolerate it, and how their bodies process it. We'll also be watching closely to see if there are any early signs that it could help improve rheumatoid arthritis symptoms. This is an important first step to understand if NBIM-1008 might be a useful treatment in the future. All participants will be adults over 18.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Neurocrine Biosciences Inc.

Enrolment target

Start

29 May 2026

Rheumatoid Arthritis

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the very first times a new medicine is being tested in humans. The medicine is called NBIM-1008, and it's designed to help people who have rheumatoid arthritis.

The main aim of this study is to make sure NBIM-1008 is safe. Doctors will be checking very carefully for any side effects and how your body reacts to the medicine. They also want to understand how the medicine moves through your body, how much stays in your system, and how quickly it's removed. This helps them work out the best dose to give in future studies.

While safety is the top priority, the researchers will also be looking for any early signs that NBIM-1008 could help improve the symptoms of rheumatoid arthritis. This study is an important step in developing new treatments for rheumatoid arthritis, and it helps doctors decide if more research in larger groups of people is worthwhile.

Key takeaways

This is a very early study testing a new medicine (NBIM-1008) for rheumatoid arthritis.
The main goals are to check if the medicine is safe and how the body handles it.
Researchers will also look for early signs that it might help ease symptoms.
Participants must be 18 years or older, and both men and women can join.
You would receive the new medicine and have regular health checks and blood tests.

Who may be eligible?

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

Because this is a very early-stage study, there will likely be specific medical requirements to ensure the safety of participants. For example, you might need to have a confirmed diagnosis of rheumatoid arthritis and possibly have tried other treatments that haven't worked well for you.

It's also common for studies like this to exclude people who have other serious health problems, are pregnant or breastfeeding, or are taking certain medications that could interfere with the study drug. The study team will discuss all the detailed requirements with you to see if you're a good fit.

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 willing to attend regular clinic visits and have tests?
Are you able to follow study instructions carefully?
Are you able to understand and give permission to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medication, NBIM-1008. Since this is an early study, you would likely have frequent visits to the clinic initially for health checks, blood tests, and to make sure you're feeling okay. These visits would help the doctors understand how the medicine is working and how your body is reacting.

You would have regular assessments, which might include giving blood samples, having your vital signs (like blood pressure and heart rate) checked, and discussing any symptoms or side effects you experience. The medicine would be given in a way specified by the study (e.g., as a tablet or injection). The total duration of your participation would depend on the study plan, but early-stage trials often involve a treatment period followed by a follow-up period to monitor your health.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research and possibly being among the first to try a new treatment that might help your rheumatoid arthritis, particularly if other treatments haven't been effective. However, because this is an early-stage drug, there's a chance it might not help your condition, and there could be unknown side effects or risks. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Romania

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. It's an autoimmune disease, meaning your body's immune system mistakenly attacks your own healthy joint tissues.

What does 'Phase 1' mean for a medical study?

Phase 1 studies are the first step in testing a new medicine in people. They mainly focus on safety, finding the right dose, and understanding how the medicine works in the body. Only a small number of people take part.

Will I know if I'm getting the new medicine?

Yes, this is an 'open-label' study, which means both you and the study doctors will know that you are receiving NBIM-1008, the new medicine being tested.

What is 'NBIM-1008'?

NBIM-1008 is the special code name for the new medicine being tested in this study. It doesn't have a commonly known name yet.

How long will the study last for me?

The exact length of your participation would be explained by the study team, but early studies often involve several weeks or months of treatment and follow-up visits.