Home › Trials › NCT07250750

IM-101 for adults with generalized 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

Phase1; Phase2 Interventional ImmunAbs Inc. · NCT07250750

This trial will try IM-101, a C5 inhibitor, in adults with AChR antibody–positive generalized myasthenia gravis and later include AChR antibody–negative generalized and ocular myasthenia gravis to see if it is safe and helps symptoms.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorImmunAbs Inc. Industry-sponsored
Locations25 sites (Altamonte Springs, Florida and 24 other locations)
Trial IDNCT07250750 on ClinicalTrials.gov

What this trial studies

This Phase 1b/2 randomized, placebo-controlled study tests IM-101, an investigational C5 complement inhibitor, first in AChR antibody–positive generalized myasthenia gravis to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics and to select a dose. After dose selection, the trial expands to evaluate the chosen regimen in AChR antibody–negative generalized MG and in participants with ocular MG compared with placebo. Participants are adults aged 18–74 on stable background MG therapy, must meet weight and vaccination requirements, and cannot be anti‑MuSK positive or previously intolerant to complement inhibitors. Dosing and follow-up occur at three clinical research centers in Florida using IM-101 and matching placebo arms.

Who should consider this trial

Good fit: Adults 18–74 with diagnosed myasthenia gravis who are on a stable background regimen, meet weight and vaccination requirements, and (for initial enrollment) are AChR antibody–positive are the ideal candidates.

Not a fit: Patients who are anti‑MuSK antibody–positive, have a history of meningococcal infection, recent cancer, or who previously failed or were intolerant to complement inhibitors are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, IM-101 could offer a new complement-targeted treatment that reduces muscle weakness and the need for other immunosuppressive medications in people with myasthenia gravis.

How similar studies have performed: Other C5 inhibitors such as eculizumab and ravulizumab have demonstrated clear benefits in AChR‑positive generalized myasthenia gravis, so the complement‑inhibition approach is supported by prior successes though IM-101 itself is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Altamonte Springs, Florida and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myasthenia GravisIM-101C5 inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.