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

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.

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.