A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorImmunAbs Inc.

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

96 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators