NL-OMON20195尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 22
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •with a positive AChR antibody test.
- •4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the
- •study restrictions.
- •5. Must be able to cease the use of pyridostigmine as per study requirements, if applicable.
排除标准
- •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
- •antibody (HIV Ab) at screening.
- •4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP)
- •greater than 90 or less than 50 mm Hg at screening.
- •5. Abnormal findings in the resting ECG at screening or baseline defined as:
- •a. QTcF> 450 or < 300 msec
- •b. Notable resting bradycardia (HR < 50 bpm) or tachycardia (HR > 100 bpm)
- •c. Personal or family history of congenital long QT syndrome or sudden death;
- •d. Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac
- •e. Ventricular tachyarrhythmia
- •f. Atrial tachyarrhythmia, fibrillation or flutter
- •g. Complete heart block (i.e. third-degree atrioventricular block) or any heart block susceptible to evolve to
- •complete heart block (first-degree atrioventricular block with markedly prolonged PR interval (= 240 ms) and/or
- •wide QRS complex (= 120 ms), second-degree atrioventricular block, bundle branch block, bifascicular and
- •trifascicular block),
- •h. Sinus node dysfunction (sinus rate < 50 bpm, sinus arrest of >3.5 sec)
- •6. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or
- •less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to
- •1g/day). Other exceptions will only be made if the rationale is clearly documented by the investigator.
- •7. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less
- •than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the
- •investigator.
- •8. Participation in an investigational drug or device study within 3 months prior to first dosing, or for more than 4
- •times a year.
- •9. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units
- •alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent
- •10. Positive test for drugs of abuse at screening or pre-dose.
- •11. Alcohol will not be allowed from at least 24 hours before screening or pre-dose.
- •12. Current use of tobacco or nicotine products and unable to abstain from use of these products within the
- •previous month before the first dose administration.
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