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NCT06106672 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
A Phase 1 study of Myasthenia Gravis and AChR Myasthenia Gravis, sponsored by COUR Pharmaceutical Development Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 17
- Study locations
NCT06106672: Recruiting Phase 1 study of Myasthenia Gravis and AChR Myasthenia Gravis, sponsored by COUR Pharmaceutical Development Company.
NCT06106672 is a Phase 1 study of Myasthenia Gravis and AChR Myasthenia Gravis that is actively recruiting participants, run by COUR Pharmaceutical Development Company. The registered enrollment target is 54 participants, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (72% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06106672, a Phase 1 study of Myasthenia Gravis and AChR Myasthenia Gravis, is actively recruiting participants, sponsored by COUR Pharmaceutical Development Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CNP-106
Study Locations (17)
Florida
- Atlantis Research - Miami
- Quantix Research, LLC - Miami
- University of South Florida - Tampa
Arizona
- Barrow Neurological Institute - Phoenix
- Neuromuscular Clinic and Research Center - Phoenix
California
- Infusion for Health - Brea
- University of California, Irvine - Orange
Texas
- Nerve and Muscle Center of Texas - Houston
- Prolato Clinical Research Center - Houston
Connecticut
- Yale University - New Haven
Illinois
- Insight Hospital and Medical Center - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- Insight Research Institute, Dearborn - Dearborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What NCT06106672 shows while recruiting
NCT06106672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (72% lower).
The record links to 4 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06106672 lists 17 locations in 12 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT06106672 about?
NCT06106672 is a clinical study titled "Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis". 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.
What is the current status of trial NCT06106672?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2024-05-30. Estimated completion is 2026-08.
What conditions does trial NCT06106672 study?
This clinical trial studies the following conditions: Myasthenia Gravis, AChR Myasthenia Gravis, Generalized Myasthenia, MuSK MG.
What interventions are being tested in trial NCT06106672?
The interventions under investigation include: Placebo (OTHER), CNP-106 (DRUG).
Who is sponsoring clinical trial NCT06106672?
This trial is sponsored by COUR Pharmaceutical Development Company, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06106672 being conducted?
This trial has 17 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06106672's enrollment target sits among peer trials
54 22nd of 32 higher than 11 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
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