CNP-106 for Myasthenia Gravis

Phase 1 & 2

Recruiting

Research Sponsored by COUR Pharmaceutical Development Company, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects of non-childbearing potential (ex. Surgical sterilization, no menses for a year)

Men and non-pregnant women, ages 18-75 years inclusive

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study day 180

Summary

This trial tests a new drug to see if it's safe, effective, and how it works in people for the first time.

Who is the study for?

Adults aged 18-75 with Myasthenia Gravis (MG), experiencing muscle weakness, who have not had certain treatments or surgeries recently. They must have specific MG symptom scores, stable medication doses for 3 months, and agree to use effective birth control. Excludes those with mild or very severe MG, recent strokes, other immune disorders requiring immunosuppressants, significant cardiovascular disease, or a history of certain cancers.

What is being tested?

The trial is testing CNP-106's safety and effectiveness in treating Myasthenia Gravis compared to a placebo. It's the first time this drug is being given to humans (First-in-Human) and will involve increasing doses to see how patients respond (multiple ascending doses).

What are the potential side effects?

Potential side effects are not detailed but may include reactions typical of new medications such as allergic responses, issues at the injection site, general discomfort or changes in blood tests that monitor organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot become pregnant (e.g., due to surgery or menopause).

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I am between 18 and 75 years old and not pregnant.

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My tests show I have anti-AChR antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My myasthenia gravis is either very mild or very severe.

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I have had a stroke in the last year.

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You have used certain medications within a specific timeframe, have specific test results, received certain vaccinations, have certain infectious diseases, or have certain medical conditions that make you unsuitable for this study.