A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants With Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Neurology of Central Florida Research Center, LLC
RECRUITING
Altamonte Springs
SFM Clinical Research, LLC
RECRUITING
Boca Raton
Aqualane Clinical Research
RECRUITING
Naples
Medsol Clinical Research Center
NOT_YET_RECRUITING
Port Charlotte
University of South Florida
NOT_YET_RECRUITING
Tampa
Missouri
University of Kansas Medical Center Research Institute, Inc.
NOT_YET_RECRUITING
Kansas City
Texas
Houston Methodist Neurological Institute
NOT_YET_RECRUITING
Houston
Nerve & Muscle Center of Texas
RECRUITING
Houston
Other Locations
Bulgaria
Medical Center Hera - branch Montana
NOT_YET_RECRUITING
Montana
MHAT Avis - Medica OOD
NOT_YET_RECRUITING
Pleven
UMHAT 'Dr. Georgi Stranski', EAD
NOT_YET_RECRUITING
Pleven
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
NOT_YET_RECRUITING
Sofia
Haelan Care 4 Medical Center EOOD
NOT_YET_RECRUITING
Varna
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
NOT_YET_RECRUITING
Brescia
Fondazione IRCCS Istituto Neurologico Carlo Besta
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Poland
Neurologia Slaska Centrum Medyczne
NOT_YET_RECRUITING
Katowice
Twoja Przychodnia NCM
NOT_YET_RECRUITING
Nowa Sól
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
NOT_YET_RECRUITING
Poznan
Twoja Przychodnia PCM
NOT_YET_RECRUITING
Poznan
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM
NOT_YET_RECRUITING
Zabrze
Serbia
General Hospital MSB Medical System Belgrade
NOT_YET_RECRUITING
Belgrade
Spain
Hospital Universitario Clinico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Clinica Universidad de Navarra
NOT_YET_RECRUITING
Pamplona
Contact Information
Primary
ImmunAbs Clinical Team
info@immunabs.com
82-2-6951-0584
Time Frame
Start Date:2026-02-05
Estimated Completion Date:2028-06
Participants
Target number of participants:96
Treatments
Experimental: Part A MAD Cohort 1
IM-101 Low dose or Placebo
Experimental: Part A MAD Cohort 2
IM-101 Mid dose or Placebo
Experimental: Part A MAD Cohort 3
IM-101 High dose or Placebo
Experimental: Part A MAD Cohort 4 (Optional)
IM-101 or Placebo if additional dose is needed per IDMC decision