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RECRUITING Phase 1

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

NCT07250750 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG IM-101 Part A
  • DRUG Placebo Part A
  • DRUG IM-101 Part B
  • DRUG Placebo Part B

Study Locations (20)

Other

  • Medical Center Hera - branch Montana — Montana
  • "MHAT Avis - Medica" OOD — Pleven
  • UMHAT 'Dr. Georgi Stranski', EAD — Pleven
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD — Sofia
  • Haelan Care 4 Medical Center EOOD — Varna
  • Neurologia Slaska Centrum Medyczne — Katowice
  • Twoja Przychodnia NCM — Nowa Sól
  • Twoja Przychodnia PCM — Poznan
  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy — Poznan

Florida

  • Neurology of Central Florida Research Center, LLC — Altamonte Springs
  • SFM Clinical Research, LLC — Boca Raton
  • Aqualane Clinical Research — Naples
  • Medsol Clinical Research Center — Port Charlotte
  • University of South Florida — Tampa

Texas

  • Nerve & Muscle Center of Texas — Houston
  • Houston Methodist Neurological Institute — Houston

Milano

  • Ospedale San Raffaele — Milan
  • Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan

Missouri

  • University of Kansas Medical Center Research Institute, Inc. — Kansas City

Brescia

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) — Brescia

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2026-02-05
Est. Completion 2028-06
Phase Phase 1

Sponsor

ImmunAbs

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07250750

The ClinicalTrials.gov registry entry for NCT07250750 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunAbs, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Myasthenia Gravis appearing as the primary indexed condition, and to 4 interventions — of which IM-101 Part A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07250750 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07250750 about?

NCT07250750 is a clinical study titled "A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis". 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 par...

What is the current status of trial NCT07250750?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2026-02-05. Estimated completion is 2028-06.

What conditions does trial NCT07250750 study?

This clinical trial studies the following conditions: Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07250750?

The interventions under investigation include: IM-101 Part A (DRUG), Placebo Part A (DRUG), IM-101 Part B (DRUG), Placebo Part B (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07250750?

This trial is sponsored by ImmunAbs, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07250750 being conducted?

This trial has 20 study locations across Florida, Missouri, Texas, Brescia, Milano. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial