NL-OMON49863已完成不适用
Randomized, double-blind, placebo-controlled single ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effects of YTX-7739, a novel oral inhibitor of Stearoyl-CoA-desaturases, in healthy volunteers - SAD and food-effect study of YTX-7739
Yumanity Therapeutics0 个研究点目标入组 56 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
- 56
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
- •1. Healthy male and female subjects 18-45 years of age, inclusive. Healthy
- •status is defined by absence of evidence of any active acute or chronic disease
- •or illness following a detailed medical and surgical history, a complete
- •physical examination including vital signs, 12-lead ECG, hematology, blood
- •chemistry, coagulation and urinalysis;
- •2. Body mass index (BMI) between 18-35 kg/m2, inclusive, and with a minimum
- •weight of 50kg and maximum weight of 120kg;
- •3. Evidence of a personally signed, dated and witnessed informed consent
- •document indicating that the subject has been informed of all pertinent aspects
- •of the study;
- •4. Able and willing to give written informed consent and to comply with all
- •study restrictions.
排除标准
- •1. Legal incapacity or inability to understand or comply with the requirements
- •of the study;
- •2. Clinically significant findings, as judged by the investigator, as
- •determined by medical history taking, physical examination, ECG and vital signs;
- •3. Subjects with a borderline QTcF of > 450 ms for males and > 470 ms for
- •females at screening or a history of long QT syndrome;
- •4. Hemodynamic status at screening: systolic blood pressure <100 or >160 mmHg,
- •diastolic blood pressure <60 or >95 mmHg or heart rate <45 or >100 bpm
- •5. Any current, clinically significant, known medical condition, as judged by
- •the investigator.
- •6. Pregnant, lactating or breast-feeding women;
- •7. Have a urine drug screen detecting illicit drug(s) of abuse (morphine,
- •benzodiazepines, cocaine, amphetamine, THC) or positive alcohol breath test at
- •8. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab)
- •or human immunodeficiency virus antibody (HIV Ab) at screening;
- •9. Consumption of, on average, >8 units/day of (methyl)xanthines (e.g., coffee,
- •tea, cola, chocolate) and/or not able to refrain from use during each stay at
- •the CHDR clinic;
- •10. History or clinical evidence of alcoholism or drug abuse;
- •11. Smoking of >5 cigarettes/day or equivalent prior to screening and/or not be
- •able to refrain from smoking cigarettes during each stay at the CHDR clinic;
- •12. Use of prescription, illicit or herbal medication within 7 days or 5
- •half-lives prior to the first day of dosing, except contraception,and
- •paracetamol. Other current and recent (within 1 month prior to the screening)
- •treatments will be allowed, if judged by the investigator to have no clinical
- •13. Participation in a clinical trial with an investigational drug or device
- •within 90 days of first dosing or more than 4 times in the previous year;
- •14. Loss or donation of blood * 500 mL within 3 months before screening;
- •15. Subjects of childbearing potential who are unwilling or unable to use a
- •highly effective method of barrier contraception for the duration of the study
- •and for at least 90 days after their last dose of study treatment.
- •16. All males who are unwilling to practice effective contraception and abstain
- •from sperm donation during the study and who are not willing and able to
- •continue contraception and abstain from sperm donation for at least 90 days
- •after their last dose of study treatment.
- •17. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug, or multiple drug allergies (non-active hay fever is
- •acceptable).
- •18. Part C, Cohort 7 only: History of spinal cord compression, any other
- •current abnormalities in the lumbar region (skin infection, structural
- •abnormalities in lower spine, etc.), or any other issue that, in the opinion of
- •the investigator, would make CSF collection unsafe
- •19. Positive SARS-CoV-2 PCR analysis prior to first dosing.
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