Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myas… (NCT06106672) | Clinical Trial Compass
Active — Not 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 range
18 Years – 75 Years
Sex
ALL
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 Screening Visit, and agree to one of the following:
. Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class II-IV.
. Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (LabCorp Central Laboratory Services Inc.).
. Subjects with MG-ADL Score ≥6 at Screening and Baseline Visit with ≥50% of the score derived from non-ocular symptoms.
. Subjects with QMG Score ≥11 at Screening and Baseline Visit.
. For subjects on any medication used to treat the symptoms of MG (e.g. Corticosteroids, pyridostigmine), subjects must be on a stable dose for a minimum of 90 days prior to enrollment and must agree not to increase their dose throughout the study duration unless reviewed and approved by the medical monitor and the site investigator.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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 may enter the study following the washout periods for medications as described below prior to screening and refrain from usage throughout the study:
. Subjects who have used immunoglobulins given SC or IV (SCIg or IVIg) or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
. Subjects who have had thymectomy or any other thymic surgery performed within 12 months prior to Screening.
. Subjects with untreated thymic malignancy, carcinoma, or thymoma.