NCT07250750 · ImmunAbs Inc.
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
(Synergy-MG)
What this study is about
The goal of this clinical trial is to assess the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body (PD), and potential effectiveness of IM-101 in adult participants with AChR antibody-positive gMG.
View original scientific description
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG. Subsequently, the safety and efficacy of the selected IM-101 dose-regimen will be tested in participants with AChR antibody-negative gMG and participants with AChR antibody-positive or AChR antibody-negative oMG.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able and willing to provide signed informed consent
- Willingness to consent to screening for genetic muscular diseases
- Male or female aged ≥ 18 years and \< 75 years
- Diagnosed with MG
- On a stable dose of background therapy for the treatment of MG
- Body weight ≥ 40 kg at screening
- Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B
Exclusion criteria
- Previous exposure to IM-101
- Anti-MuSK antibody Positive
- History of malignant thymoma, or history of cancer within the past 5 years of screening
- History of N. meningitidis infection
- Has been treated with any complement inhibitor, but failed due to intolerability or lack of efficacy Full eligibility criteria is available in the study protocol.
Where
- Altamonte Springs, Florida
- Boca Raton, Florida
- Naples, Florida
- Port Charlotte, Florida
- Tampa, Florida
- Kansas City, Missouri
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations