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RecruitingPhase 1/Phase 2

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

ImmunAbs Inc. · NCT07250750

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–74 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
96
US sites recruiting
4
Study start
February 5, 2026
Record last updated
February 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: IM-101 Part A; Placebo Part A; IM-101 Part B; Placebo Part B

Conditions: Myasthenia Gravis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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
  • On a stable dose of background therapy for the treatment of MG
  • Body weight ≥ 40 kg at screening
  • Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B

Exclusion Criteria

  • 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
  • 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.

Recruiting US locations

  • Neurology of Central Florida Research Center, LLC

    Altamonte Springs, FL 32714

    Site contact: Adiana Perez · 4077904904 · adiresearchcfl@gmail.com

  • SFM Clinical Research, LLC

    Boca Raton, FL 33487

    Site contact: Gabrielle DeMaria · 5619390333 · gabrielle@sfmresearch.com

  • Aqualane Clinical Research

    Naples, FL 34105

    Site contact: Matthew Cagney · 2395296780 · matthewc@aqualaneresearch.com

  • Nerve & Muscle Center of Texas

    Houston, TX 77030

    Site contact: Amy Megerle · 7137950033 · houneuamy@msn.com

Study contacts (from the official record)

  • ImmunAbs Clinical Team · 82-2-6951-0584 · info@immunabs.com
All phase 1 studies in Florida →
A Phase 1b/2 Study of IM-101 in Adult Participants With… (NCT07250750) | Bored Studies