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NCT07250750 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
A Phase 1 study of Myasthenia Gravis, sponsored by ImmunAbs.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT07250750: Recruiting Phase 1 study of Myasthenia Gravis, sponsored by ImmunAbs.
NCT07250750 is a Phase 1 study of Myasthenia Gravis that is actively recruiting participants, run by ImmunAbs. The registered enrollment target is 96 participants, below the 188-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07250750, a Phase 1 study of Myasthenia Gravis, is actively recruiting participants, sponsored by ImmunAbs.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/bir
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
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2026-02-05 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
What NCT07250750 shows while recruiting
NCT07250750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 188-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (49% lower).
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.
NCT07250750 names 20 study sites across 6 states, led by Other, Florida, Texas.
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.
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).
Who is sponsoring clinical trial NCT07250750?
This trial is sponsored by ImmunAbs, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07250750's enrollment target sits among peer trials
96 17th of 32 higher than 16 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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