NL-OMON40606已完成不适用
Randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in healthy male subjects (part 1), and a subsequent parallel open label study in healthy male and female subjects and MS patients (part 2), to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201. - Safety, PK and PD study with 2B3-201.
to-BBB technologies BV0 个研究点目标入组 54 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
- 54
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
- •Healthy subjects (cohorts 1-7):
- •1. Healthy male (cohorts 1-6) and female (cohort 7) subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions.;MS subjects (cohorts 8 and 9)
- •1. Age: 18 to 65 years, both men and women.
- •2. Patients with relapsing multiple sclerosis (RMS), defined as below, with an acute exacerbation, who in the opinion of the treating physician should undergo a 3 - 5 day course of high dose methylprednisolone;
- •o Patients with Relapsing Remitting Multiple Sclerosis (RRMS).
- •o Patients with Secondary Progressive Multiple Sclerosis (SPMS) and superimposed relapses.
- •o Patients with clinically isolated syndromes (CIS) who show dissemination of lesions in time (DIT) and space (DIS) on MRI scans according to the 2010 McDonald criteria.
- •3. Able to participate and willing to comply with the study restrictions. Understands and signs the written informed consent prior to any of the testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
排除标准
- •Healthy volunteers (cohorts 1-7):
- •1. Subjects not willing to use contraception, for the duration of the study and for 3 months after the last dose.
- •2. Positive test for drugs at screening or pre-dose.
- •3. History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited during study confinement and at least 48 hours before screening, before dosing, and before each scheduled visit.
- •4. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •6. 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.
- •7. Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration. Exceptions are paracetamol (up to 4 g/day).
- •8. Use of CYP3A4-inhibiting drugs, including quinine containing drinks (bitter lemon and tonic water) is prohibited within 21 days of study drug administration
- •9. Subject has used grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, or pomelo-containing products, within 14 days prior to day -1.
- •10. 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.
- •11. Participation in an investigational drug or device study within 3 months prior to screening.
- •12. Donation of blood over 500 mL within three months prior to screening.
- •13. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- •14. Smoker of more than 10 cigarettes per day prior to screening or who use tobacco products equivalent to more than 10 cigarettes per day.
- •15. Clinically significant abnormal ECG, as judged by the Investigator.
- •16. Current infection or inflammation study within 1 month prior to screening
- •17. Recent vaccinations study within 3 months prior to screening.
- •18. Positive Mantoux test of 5 mm or more.
- •19. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- •20. Unwillingness or inability to comply with the study protocol for any other reason.
- •21. Any subject who is pregnant or breastfeeding. A urine pregnancy test should be performed in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) prior to the start of the study treatment.
- •22. For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile
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