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

Part of paid clinical trials in Altamonte Springs, Florida.

Sponsor
ImmunAbs Inc.
Study ID
NCT07250750
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • IM-101 Part A — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: Part B Expansion AChR positive gMG
    IM-101 or Placebo
  • Experimental: Part B Expansion AChR negative gMG
    IM-101 or Placebo
  • Experimental: Part B Expansion oMG
    IM-101 or Placebo

Primary Outcome Measure

[Part A] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs across 3 ascending dose regimens (each with 3 administrations) in participants with AChR antibody-positive gMG [ Time Frame: From first dose of study drug (Day 1) up to 70 days after the last dose of study drug, up to approximately 99 days. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Neurology of Central Florida Research Center, LLCAltamonte SpringsFlorida32714
Adiana Perez
[email protected]
4077904904
SFM Clinical Research, LLCBoca RatonFlorida33487
Gabrielle DeMaria
[email protected]
5619390333
Aqualane Clinical ResearchNaplesFlorida34105
Matthew Cagney
[email protected]
2395296780
Medsol Clinical Research CenterPort CharlotteFlorida33952
Rachel Klasmeyer
[email protected]
9416239744
University of South FloridaTampaFlorida33612
Jamie Reddish
[email protected]
8139749413
University of Kansas Medical Center Research Institute, Inc.Kansas CityMissouri66103
Andrew Heim
[email protected]
9139459926
Houston Methodist Neurological InstituteHoustonTexas77070
Aramide Balogun
[email protected]
7134416947
Nerve & Muscle Center of TexasHoustonTexas77030
Amy Megerle
[email protected]
7137950033

Find similar trials in Altamonte Springs, FL

By research site
Neurology of Central Florida Research Center, LLC· Altamonte Springs, FLSFM Clinical Research, LLC· Boca Raton, FLAqualane Clinical Research· Naples, FLMedsol Clinical Research Center· Port Charlotte, FLUniversity of South Florida· Tampa, FLUniversity of Kansas Medical Center Research Institute, Inc.· Kansas City, MO

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