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

Last updated: February 9, 2026
Sponsor: ImmunAbs Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuropathy

Polymyositis (Inflammatory Muscle Disease)

Treatment

Placebo Part A

IM-101 Part A

Placebo Part B

Clinical Study ID

NCT07250750
IM-101_MG_2.1
2025-522406-20-00
  • Ages 18-74
  • All Genders

Study Summary

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

Inclusion

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), streptococcuspneumoniae, and haemophilus influenzae type B

Exclusion

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 ofscreening

  4. History of N. meningitidis infection

  5. Has been treated with any complement inhibitor, but failed due to intolerability orlack of efficacy

Full eligibility criteria is available in the study protocol.

Study Design

Total Participants: 96
Treatment Group(s): 4
Primary Treatment: Placebo Part A
Phase: 1/2
Study Start date:
February 05, 2026
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Medical Center Hera - branch Montana

    Montana 729114, 3400
    Bulgaria

    Site Not Available

  • "MHAT Avis - Medica" OOD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia 727011, 1527
    Bulgaria

    Site Not Available

  • Haelan Care 4 Medical Center EOOD

    Varna 726050, 9009
    Bulgaria

    Site Not Available

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia 3181554, Brescia 25123
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan 6951411, Milano 20133
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan 6951411, Milano 20132
    Italy

    Site Not Available

  • Neurologia Slaska Centrum Medyczne

    Katowice 3096472, 40-689
    Poland

    Site Not Available

  • Twoja Przychodnia NCM

    Nowa Sól 3090764, 67-100
    Poland

    Site Not Available

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

    Poznan 3088171, 61-853
    Poland

    Site Not Available

  • Twoja Przychodnia PCM

    Poznan 3088171, 60-324
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM

    Zabrze 3080985, 41-800
    Poland

    Site Not Available

  • General Hospital MSB Medical System Belgrade

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Hospital Universitario Clinico San Carlos

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, Madrid 3117732 28046
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Neurology of Central Florida Research Center, LLC

    Altamonte Springs 4145941, Florida 4155751 32714
    United States

    Active - Recruiting

  • SFM Clinical Research, LLC

    Boca Raton 4148411, Florida 4155751 33487
    United States

    Active - Recruiting

  • Aqualane Clinical Research

    Naples 4165565, Florida 4155751 34105
    United States

    Active - Recruiting

  • Medsol Clinical Research Center

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City 4393217, Missouri 4398678 66103
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston 4699066, Texas 4736286 77070
    United States

    Site Not Available

  • Nerve & Muscle Center of Texas

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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