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NCT06106672
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
Conditions: Myasthenia Gravis, Generalized Myasthenia, AChR Myasthenia Gravis, MuSK MG
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 54
Sponsor: COUR Pharmaceutical Development Company, Inc.
Location: Barrow Neurological Institute Phoenix Arizona
Summary
Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106.
Eligibility Criteria
Inclusion Criteria:
1. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
2. Men and non-pregnant women, ages 18-75 years inclusive.
3. Female subjects of childbearing potential must agree not to become pregnant during the clinical study, have a negative pregnancy test at Screening Visit, and agree to one of the following:
* Use two highly effective forms of birth control starting at initial screening and continuing throughout the study duration.
* Practice abstinence starting at initial screening and continuing throughout the study duration.
4. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class II-IV.
5. Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (LabCorp Central Laboratory Services Inc.).
6. Subjects with MG-ADL Score ≥6 at Screening and Baseline Visit with ≥50% of the score derived from non-ocular symptoms.
7. Subjects with QMG Score ≥11 at Screening and Baseline Visit.
8. For subjects on any medication used to treat the symptoms of MG (e.g. Corticosteroids, pyridostigmine), subjects must be on a stable dose for a minimum of 90 days prior to enrollment and must agree not to increase their dose throughout the study duration unless reviewed and approved by the medical monitor and the site investigator.
9. Female subjects who agree to not breastfeed starting at initial screening and throughout the study duration.
10. Female subjects who agree to not donate ova starting at initial screening and throughout the study duration.
11. Male subjects with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the study duration.
Exclusion Criteria:
1. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class I or V.
2. Subjects with a history of cerebrovascular accident in the past 12 months.
3. Subjects with MG-ADL Score \
Source: ClinicalTrials.gov (NCT06106672). StuddyBuddy aggregates publicly available trial information.