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A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Sponsor: ImmunAbs Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-02-05
Completion Date
2028-06
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
IM-101 Part A
Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29.
Placebo Part A
Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
IM-101 Part B
Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.
Placebo Part B
Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.
Locations (25)
Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Missouri, United States
Nerve & Muscle Center of Texas
Houston, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Medical Center Hera - branch Montana
Montana, Bulgaria
"MHAT Avis - Medica" OOD
Pleven, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, Bulgaria
Haelan Care 4 Medical Center EOOD
Varna, Bulgaria
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Brescia, Italy
Ospedale San Raffaele
Milan, Milano, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milano, Italy
Neurologia Slaska Centrum Medyczne
Katowice, Poland
Twoja Przychodnia NCM
Nowa Sól, Poland
Twoja Przychodnia PCM
Poznan, Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM
Zabrze, Poland
General Hospital MSB Medical System Belgrade
Belgrade, Serbia
Hospital Universitario Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain