ImmunAbs Inc.
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 p…
Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29.
Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.
Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.