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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106672
Other study ID # CNP-106-5.001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 30, 2024
Est. completion date August 2026

Study information

Verified date June 2024
Source COUR Pharmaceutical Development Company, Inc.
Contact Jason Penix
Phone 773-339-5745
Email jpenix@courpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a 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. 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CNP-106
CNP-106 is comprised of an antigenic AChR Peptide Pool (~1 µg of each AChRa and AChRe peptide comprising AChR Peptide Pool Drug Substance per mg particles) dispersed within a negatively charged (-30 to -60 mV) polymer matrix of PLGA (Poly (DL-lactide-co-glycolide, 50:50 acid-end group)) particles (400-800 nm in size).
Other:
Placebo
CNP-106 Placebo

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Sponsors (1)

Lead Sponsor Collaborator
COUR Pharmaceutical Development Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to COUR Pharmaceuticals Development Company, Inc. Confidential CNP-106-5.001 Protocol; IND 28774 Page 53 of 65 discontinuation from IP and study, by severity, and by causality. No formal statistical testing will be done. Through study day 180
Secondary Change from baseline in antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180. The mean change from Baseline to the endpoint within CNP-106 and Placebo treatment groups will be analyzed using ANOVA. Through study day 180
Secondary Change from baseline in activated antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180. The mean change from Baseline to the endpoint within CNP-106 and Placebo treatment groups will be analyzed using ANOVA. Through study day 180
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