Recruiting
Phase 1
Phase 2

IM-101

Sponsor:

ImmunAbs Inc.

Code:

NCT07250750

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IM-101 Part A

Placebo Part A

IM-101 Part B

Placebo Part B

Study Details

Brief 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.

Conditions

Myasthenia Gravis

Study ID

NCT07250750

Start date

Feb 5, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

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. ]
  • [Part B] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs of IM-101, compared with placebo, in participants with AChR antibody-positive gMG, AChR antibody-negative gMG, and oMG [ Time Frame: From first dose of study drug (Day 1) up to 84 days after the last dose of study drug, up to approximately 169 days. ]
  • [Part B] Change from baseline to Week 16 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score for gMG cohorts [ Time Frame: Baseline, Week 16 ]
  • [Part B]Change from baseline to Week 16 in Myasthenia Gravis Impairment Index (MGII) ocular score for oMG cohorts [ Time Frame: Baseline, Week 16 ]

Central Contacts and Locations

Central contacts

ImmunAbs Clinical Team

82-2-6951-0584info@immunabs.com

Locations

Neurology of Central Florida Research Center, LLC

Recruiting

Altamonte Springs, Florida, United States, 32714

Contacts

Adiana Perez

4077904904adiresearchcfl@gmail.com

SFM Clinical Research, LLC

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Gabrielle DeMaria

5619390333gabrielle@sfmresearch.com

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

Matthew Cagney

2395296780matthewc@aqualaneresearch.com

Nerve & Muscle Center of Texas

Recruiting

Houston, Texas, United States, 77030

Contacts

Amy Megerle

7137950033houneuamy@msn.com

More Information

Sponsor

ImmunAbs Inc.

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • IM-101
  • Myasthenia Gravis
  • C5 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by ImmunAbs Inc. on 2026-02-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.