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