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Clinical study to investigate A) the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of IM-101.
THE PRIMARY OBJECTIVE OF PART B IS TO FURTHER EVALUATE THE SAFETY OF THE STUDY DRUG AND HOW WELL IT IS TOLERATED BY THE BODY IN A LARGER NUMBER OF PEOPLE WITH MYASTHENIA GRAVIS (MG). THE STUDY WILL ALSO ASSESS WHETHER THE STUDY DRUG IS EFFECTIVE IN PEOPLE WITH GENERALIZED MYASTHENIA GRAVIS (GMG) AND OCULAR MYASTHENIA GRAVIS (OMG).
Technical Summary
- PHASE IB/II, 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 WITH IM-101 IN ADULT PARTICIPANTS WITH GENERALIZED MYASTHENIA GRAVIS AND OCULAR MYASTHENIA GRAVIS.
- Code EudraCT: 2025-522406-20-00
- Protocol number: IM-101-MG
- Promoter: ImmunAbs Inc
- Molecule/Drug: IM-101
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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