A study to evaluate the sensitivity of muscle velocity recovery cycles to determine changes in muscle excitability,by evaluating pharmacological effects in healthy subjects, and by comparing healthy subjects with myastheniagravis patients

CHDR0 sites22 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Method development for testing medication that is in development formuscular diseases.
Sponsor: CHDR
Enrollment: 22
Status: Not yet recruiting
Last Updated: last year

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•1\. Signed informed consent prior to any study\-mandated procedure
•2\. Healthy male subjects, 18 to 45 years of age, inclusive at screening.
•3\. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
•4\. All subjects must practice effective contraception during the study and be willing and able to continue
•contraception for at least 90 days after their last dose of study treatment.
•5\. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the
•study restrictions.
•1\. Signed informed consent prior to any study\-mandated procedure
•2\. Male and female subjects, above 18 years of age, inclusive at screening.
•3\. Diagnosis of generalized myasthenia gravis, MGFA class II\-IV, based on characteristic muscle weakness and

•1\. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion
•of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic
•blood pressure, pulse rate, body temperature) and 12\-lead electrocardiogram (ECG)). Minor deviations from the
•normal range may be accepted, if judged by the Investigator to have no clinical relevance.
•2\. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and
•renal panels, complete blood count, chemistry panel and urinalysis). Subjects with pre\-dose findings of clinically
•significant changes in electrolytes should be excluded. In the case of uncertain or questionable results, tests
•performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically
•irrelevant for healthy subjects.
•3\. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus