AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

This research study is looking for adults with Myasthenia Gravis (MG), including those with generalized MG (gMG) and ocular MG (oMG). The main goal is to test a new medicine called IM-101. Researchers want to understand if IM-101 is safe to use and what effects it has on the body. They will be giving different doses to see how people respond. For those in the later part of the study, the aim is to see if IM-101 helps to improve daily symptoms of MG, like muscle weakness or eye problems. This is an important step in finding new treatments for MG.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Immunabs Inc.

Enrolment target

Start

18 Feb 2026

Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

What is this study about?

This study is investigating a new medicine called IM-101 for people living with Myasthenia Gravis (MG). MG is a condition that causes muscle weakness in different parts of the body. There are two main types being studied here: generalized MG (gMG), which affects muscles more widely, and ocular MG (oMG), which mainly affects the eye muscles.

The study has two main parts. The first part focuses on safety. Researchers will give different low doses of IM-101 to a small group of participants. They'll carefully watch for any side effects and learn how the medicine behaves in the body. The goal is to find a safe and effective dose.

In the second part, more people will join, and the study will look at how well IM-101 works to improve MG symptoms, in addition to continuing to monitor safety. Researchers will measure changes in daily activities and specific MG symptoms to see if the medicine makes a difference. This type of study is a crucial step in developing new treatments that could help people with MG feel better.

Key takeaways

This study is testing a new medicine (IM-101) for Myasthenia Gravis.
It's looking at both safety and how well the medicine improves symptoms.
Adults with generalized or ocular MG may be eligible.
Some participants will receive IM-101, others a placebo.
Regular clinic visits and health checks will be part of participation.
The findings could help develop new treatments for MG.

Who may be eligible?

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

Most importantly, you must have been diagnosed with either Generalized Myasthenia Gravis (gMG) or Ocular Myasthenia Gravis (oMG). The doctors will check your medical history and current health to make sure the study is a safe and suitable option for you.

There might be other specific health requirements or medications you're taking that could affect whether you can join. These will be discussed with you 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?
Have you been diagnosed with Generalized Myasthenia Gravis (gMG)?
Or have you been diagnosed with Ocular Myasthenia Gravis (oMG)?
Are you willing to attend regular clinic visits?
Are you comfortable with potentially receiving a placebo?
Are you open to receiving study-related vaccinations?

Answer every question to see your result.

What does participation involve?

If you join this study, you might receive the new medicine IM-101 (at different doses) or a dummy medicine called a placebo, which looks like IM-101 but has no active drug. This is done to fairly compare how the actual medicine works. You will also receive some common vaccines, such as those for pneumonia, meningitis, and diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b, as part of the study.

You'll have regular visits to the study clinic where doctors and nurses will monitor your health. This will involve physical check-ups, blood tests, and heart tracings (ECGs). You'll also be asked to complete questionnaires about your MG symptoms and how you're feeling. The study will last for a number of weeks, and the team will explain the full schedule of visits and assessments to you.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing to medical knowledge about MG and possibly improving your own symptoms if you receive the active study medicine. However, there are also potential risks, including side effects from the study medicine or the vaccines, which could be mild or, less commonly, more serious. The study team will explain all known risks to you. Remember, joining 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 (4)

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

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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Spain
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Unverified
Italy

Common questions

What is Myasthenia Gravis (MG)?

MG is a long-term condition that causes muscle weakness and tiredness, which can affect different parts of the body, including the eyes, face, and limbs.

What does 'Phase 1b/2' mean?

This means the study is still in early stages. It's looking closely at the medicine's safety and how it works in the body (Phase 1b), and also starting to see how well it helps symptoms in a larger group of people (Phase 2).

What is a 'placebo'?

A placebo is a dummy medicine that contains no active drug, but looks exactly like the real medicine. It's used to compare the effects of the actual medicine fairly.

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 doctors will know who is receiving the active medicine or the placebo until after the study is over. This helps ensure fair results.

What are 'TEAEs' and 'SAEs'?

TEAEs are 'Treatment-Emergent Adverse Events' – any health problems that appear or get worse during the study. SAEs are 'Serious Adverse Events' which are more severe health problems that might happen.