A Phase 1b/2a Double Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-106 in Subjects Ages 18–75 with Generalized Myasthenia Gravis

Date Added
January 16th, 2025
PRO Number
Pro00136862
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

Subjects ages 18–75 with generalized myasthenia gravis (MG) will be screened up to 42 days prior to enrollment into the clinical study. Note: If subjects are currently on a standard of care therapy, they will remain on their current standard of care therapy during the course of the clinical study at the discretion of the Investigator.
Subjects who meet all inclusion and no exclusion criteria after completing the Screening Visit will be enrolled in the clinical study.
Subjects will be randomized on Day 1 into the current cohort in a 2:1 ratio to receive two separate administrations of intravenous CNP-106 or Placebo (0.9% Sodium Chloride Injection USP) on Day 1 and Day 8. Investigational Product (IP) will be administered by IV infusion over approximately 3-4 hours using a graduated rate of infusion. Subjects will undergo medical observation in the clinic for acute AEs for 4 hours following infusion on Day 1 and Day 8.

Institution
MUSC
Recruitment Contact
Alison Line
8437922845
line@musc.edu



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