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A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
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
Who can join
Ages 18 to 74 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Able and willing to provide signed informed consent 2. Willingness to consent to screening for genetic muscular diseases 3. Male or female aged ≥ 18 years and \< 75 years 4. Diagnosed with MG 5. On a stable dose of background therapy for the treatment of MG 6. Body weight ≥ 40 kg at screening 7. Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B Exclusion Criteria: 1. Previous exposure to IM-101 2. Anti-MuSK antibody Positive 3. History of malignant thymoma, or history of cancer within the past 5 years of screening 4. History of N. meningitidis infection 5. 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.
About the study
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.
What is being tested
- IM-101 Part A (drug)
- Placebo Part A (drug)
- IM-101 Part B (drug)
- Placebo Part B (drug)
Sponsor: ImmunAbs Inc. · Participants: 96 · Started: Feb 5, 2026
Contact the study team
- ImmunAbs Clinical Team · Phone: 82-2-6951-0584
Official record on ClinicalTrials.gov — NCT07250750
Locations in the U.S.
| Florida | Neurology of Central Florida Research Center, LLC, Altamonte Springs SFM Clinical Research, LLC, Boca Raton Aqualane Clinical Research, Naples Medsol Clinical Research Center, Port Charlotte (Not yet recruiting) University of South Florida, Tampa (Not yet recruiting) |
| Missouri | University of Kansas Medical Center Research Institute, Inc., Kansas City (Not yet recruiting) |
| Texas | Houston Methodist Neurological Institute, Houston (Not yet recruiting) Nerve & Muscle Center of Texas, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.