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NCT07250750PHASE1, PHASE2Recruiting

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

ImmunAbs Inc.

Start Date

2/5/2026

Completion Date

6/1/2028

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

Age Range: 18 years to 74 years

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 past 5 years of screening 4. History of N. meningitidis infection 5. 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.

Interventions

DRUG

IM-101 Part A

DRUG

Placebo Part A

DRUG

IM-101 Part B

DRUG

Placebo Part B

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Conditions

Myasthenia Gravis

Locations

Neurology of Central Florida Research Center, LLC

Altamonte Springs, Florida 32714

United States

SFM Clinical Research, LLC

Boca Raton, Florida 33487

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

Medsol Clinical Research Center

Port Charlotte, Florida 33952

United States

University of South Florida

Tampa, Florida 33612

United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Missouri 66103

United States

Nerve & Muscle Center of Texas

Houston, Texas 77030

United States

Houston Methodist Neurological Institute

Houston, Texas 77070

United States

Medical Center Hera - branch Montana

Montana, 3400

Bulgaria

"MHAT Avis - Medica" OOD

Pleven, 5800

Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800

Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, 1527

Bulgaria

Haelan Care 4 Medical Center EOOD

Varna, 9009

Bulgaria

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

Brescia, Brescia 25123

Italy

Ospedale San Raffaele

Milan, Milano 20132

Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milano 20133

Italy

Neurologia Slaska Centrum Medyczne

Katowice, 40-689

Poland

Twoja Przychodnia NCM

Nowa Sól, 67-100

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

Poznan, 61-853

Poland

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

Zabrze, 41-800

Poland

General Hospital MSB Medical System Belgrade

Belgrade, 11000

Serbia

Hospital Universitario Clinico San Carlos

Madrid, Madrid 28040

Spain

Hospital Universitario La Paz

Madrid, Madrid 28046

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain