Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06106672
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-10-24
Brief Title:
Evaluate the Safety Tolerability Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
Sponsor:
COUR Pharmaceutical Development Company Inc
Organization:
COUR Pharmaceutical Development Company Inc
Study Overview
Official Title:
A Phase 1b2a Double Blind Placebo Controlled Study to Evaluate the Safety Tolerability Pharmacodynamics and Efficacy of CNP-106 in Subjects Ages 18-75 With Generalized Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1b2a First-in-Human FIH clinical trial to assess the safety tolerability pharmacodynamics PD and efficacy of multiple ascending doses of CNP-106
Detailed Description:
This is a Phase 1b2a First-in-Human FIH clinical trial to assess the safety tolerability pharmacodynamics PD and efficacy of multiple ascending doses of CNP-106 The clinical study lasts 222-days up to 42 days for Screening 180 Study Days Subjects ages 18-75 with generalized myasthenia gravis MG will be screened up to 42 days prior to enrollment into the clinical study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None