About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IM-101 Part A
- Placebo Part A
- IM-101 Part B
- Placebo Part B
Treatment groups
7
Treatment groupsSee each treatment group below.