NL-OMON49667已完成不适用
A randomized, double-blind, placebo-controlled single and multiple ascending dose study to test the safety, tolerability, pharmacokinetics and pharmacodynamics of NT-0167 in healthy volunteers - SAD and MAD of NT-0167 in healthy volunteers
odThera0 个研究点目标入组 80 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
- 80
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
- •Eligible subjects must meet all of the following inclusion criteria at
- •1. Signed informed consent and willing and able to comply with the study
- •2. Healthy men or women of non-child bearing potential (WONCBP), 18 to 55 years
- •of age (inclusive) at screening. The health status is verified by absence of
- •evidence of any clinically significant active or uncontrolled chronic disease
- •following a detailed medical history, a complete physical examination including
- •vital signs, laboratory measurements, and 12-lead ECG;
- •3. Female subjects must be of non-childbearing potential in accordance with one
- •of the following definitions:
- •* Surgically sterile (by hysterectomy and/or bilateral oophorectomy and/or
- •bilateral salpingectomy) as documented by a surgical report or by ultrasound, or
- •* Post-menopausal (age-appropriate spontaneous amenorrhoea for *12 months and
- •follicle-stimulating hormone (FSH) * 40 IU/mL together with the absence of oral
- •contraceptive use for >12 months);
- •4. Male volunteers agree to use barrier protection when they engage in sexual
- •relations with women of child-bearing potential (WOCBP) or lactating women for
- •the duration of their participation in the study and until 90 days after EOS.
- •5. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum
- •bodyweight of 50 kg;
- •6. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
- •7. Have the intention to be reachable by mobile phone or e-mail during the
- •whole study period
排除标准
- •Eligible subjects must not meet any of the following exclusion criteria at
- •screening or pre-dose:
- •1. Lactating females;
- •2. Female volunteers with a positive pregnancy test at screening or baseline
- •prior to IMP administration;
- •3. Evidence (including symptoms, physical signs, and/or laboratory values) of
- •any active or chronic disease or condition that could interfere with, or for
- •which the treatment might interfere with, the conduct of the study, or that
- •would pose an unacceptable risk to the subject in the opinion of the
- •investigator;
- •4. Any confirmed or suspected disease or condition associated with immune
- •system impairment, including auto-immune diseases, HIV, asplenia or recurrent
- •severe infections.
- •5. Use of chronic (more than 14 days) immunosuppressant or immunomodulatory
- •drugs within the 6 months prior to IMP administration, or isolated
- •(non-chronic) use within 30 days prior to IMP administration;
- •6. Any history of severe allergic reaction(s);
- •7. Any confirmed significant drug hypersensitivity reactions (including skin
- •reactions or anaphylaxis), or known allergies (non-active hay fever is
- •acceptable);
- •8. History of clinically significant systemic disorders including
- •haematological, renal, endocrine, gastrointestinal, hepatic, cardiovascular,
- •pulmonary, dermatological and neurological disorders, or other conditions which
- •could interfere with the interpretation of the study results or compromise the
- •health of the volunteers;
- •9. Any history of psychiatric condition that may affect participation in the
- •study or preclude compliance with the protocol;
- •25. Receipt of any vaccination with 3 months of IMP administration.
- •26. Participation in an investigational drug, vaccine or device study within 3
- •months prior to first dosing or plans to participant in other investigational
- •drug, vaccine or device research during the study period.
- •27. Previous participation in a study with an investigational drug or device
- •involving the dosing of a biological targeted at any immune pathway within one
- •year prior to screening;
- •38. Any other known factor, condition, or disease that, in the opinion of the
- •Investigator, might interfere with treatment compliance, study conduct or
- •interpretation of the results, or may compromise volunteer safety.
研究者
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