NL-OMON21001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-desaturase (SCD), in healthy volunteers
Yumanity Therapeutics0 个研究点目标入组 48 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
- 48
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
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 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
- •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 screening.
- •8. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening;
- •10. History or clinical evidence of alcoholism or drug abuse;
- •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).
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