NL-OMON54930已完成不适用
A randomised, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in male and female healthy subjects and patients with myasthenia gravis. - Safety, pharmacokinetics and pharmacodynamic effects of NMD670
MD Pharma A/S0 个研究点目标入组 79 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Main inclusion criteria healthy volunteers (Part A and B)
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Part A1: Healthy male subjects, 18 to 45 years of age, inclusive at
- •3. Part A2: Healthy female subjects of non-childbearing potential, 18-65 years
- •of age, inclusive at screening.
- •4. Part B: Healthy male subjects 18-65 years of age, inclusive at screening.
- •5. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •6. All males 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.
- •7. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
- •Main inclusion criteria myasthenia gravis patients (Part C)
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Male and female subjects 18 and above years of age, inclusive at screening.
- •3. Diagnosis of myasthenia gravis, MGFA class I, II, III or IVa, based on
- •characteristic muscle weakness and a positive AChR or muscle-specific tyrosine
- •kinase (MuSK) antibody test. Subjects with MGFA 0 using pyridostigmine
- •(mestinon) may be included, if muscle weakness is present when refraining from
- •pyridostigmine (as assessed by a medical doctor based on an interview of the
- •patient at screening).
- •4. Patients using steroids should be using a stable dose of steroids for at
- •least 1 month before dosing, and the dose of steroids should be expected to
- •remain stable for the duration of the study.
- •5. Body mass index (BMI) between 18 and 34 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •6. All women of child bearing potential and all males 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.
- •7. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
- •8. Must be able to cease the use of pyridostigmine as per study requirements,
- •if applicable.
排除标准
- •Main exclusion criteMain exclusion criteria healthy volunteers (Part A and B)
- •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
- •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). 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. 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.
- •4. Positive test for drugs of abuse at screening or pre-dose. Retesting is
- •allowed at the discretion of the Investigator.
- •5. Alcohol will not be allowed from at least 24 hours before screening or
- •6. Smoker of more than 10 cigarettes per day prior to screening or who use
- •tobacco products equivalent to more than 10 cigarettes per day and unable to
- •abstain from smoking whilst in the unit.
- •7. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug, or multiple drug allergies (non-active hay fever is
- •acceptable).
- •8. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or
- •alcohol dependence or psychiatric disease.
- •9. History of trauma to the lower extremities or other conditions (most
- •importantly neurological or muscle diseases) that, in the opinion of the
- •investigator, could affect the electrophysiological measurements.
- •10. Excessive exercise within 7 days before study drug administration.
- •11. Clinically significant abnormalities in coagulation.
- •Main exclusion criteria myasthenia gravis patients (Part C)
- •1. Evidence of any active or chronic disease or condition apart from myasthenia
- •gravis, 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)). 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).
- •5. Use of any medicati
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