Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myas… (NCT06106672) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
United States54 participantsStarted 2024-05-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
✓. Men and non-pregnant women, ages 18-75 years inclusive.
✓. Female subjects of childbearing potential must agree not to become pregnant during the clinical study, have a negative pregnancy test at the Screening Visit, and agree to one of the following:
✓. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class III-IV (Cohort 1). Upon successful DMC review and approval of preliminary safety data obtained from Cohort 1 through Day 15, Cohort 2 will enroll subjects with MGFA Clinical Classification Class II-IV.
✓. Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (Mayo Clinic).
Exclusion criteria
✕. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class I or V.
✕. Subjects with a history of cerebrovascular accident in the past 12 months.
✕. Subjects with MG-ADL Score \< 6 at Screen or Subjects with MG-ADL Score ≥ 6 at Screen with ˂ 50% of the score derived from non-ocular symptoms.
✕. Subjects with QMG Score \< 11 at Screen.
✕. Subjects who have used the following medications:
✕. Subjects who have used immunoglobulins given SC or IV (SCIg or IVIg) or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
What they're measuring
1
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs),
Timeframe: Through study day 180
Trial details
NCT IDNCT06106672
SponsorCOUR Pharmaceutical Development Company, Inc.