NL-OMON42834已完成不适用
A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of DNL104 in Healthy Subjects - Single Ascending Oral Doses of DNL104
Denali 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
- 年龄范围
- 18 至 64（—）
入选标准
- •1.Healthy male or female of non-childbearing potential between 18 to 65 years of age at screening (inclusive).
- •2.Subjects must be willing and able to give written informed consent by signing an EC-approved Informed Consent Form prior to admission to
- •this study.
- •3.Body mass index between 19 to 32 kg/m2 (inclusive) and a weight of at least 50 kg.
- •4.For males: subject and his female spouse/partners who are of childbearing potential must use highly effective contraception when
- •engaging in sexual activity consisting of 2 forms of birth control (1 of which must be a barrier method such as latex or polyurethane condoms)
- •starting at screening and continuing throughout the clinical study period, and for 90 days after the final study drug administration.
- •5.For males: subject must not donate sperm starting at screening and throughout the clinical study period, and for 90 days after the final study
- •drug administration.
- •6.For females: subject must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of <200 pmol/L and follicle-stimulating hormone level of >40 IU/L at screening).
- •7.Able to communicate with the investigator and study staff.
- •8.Willing and able to comply with the requirements of the study, scheduled visits, laboratory tests, and other study procedures.
- •9.Agrees to abide by study restrictions and agrees to remain in the study unit for the confinement period.
排除标准
- •1. History of clinically significant hematological, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders.
- •2. Current significant medical or psychiatric condition.
- •3. Clinical laboratory test values outside the normal range at screening or baseline unless assessed by the Investigator as clinically non-significant values.
- •4. History or presence of supine systolic blood pressure <90 or >140 mmHg, supine diastolic blood pressure <50 or >90 mmHg, pulse rate <40 or >110 bpm, or elevated body temperature at screening or baseline.
- •5. Serious adverse reaction or serious hypersensitivity to any drug.
- •6. Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 x the upper limit of normal (ULN) or bilirubin >1.2 x ULN, or GGT >2.5 x ULN, or creatinine clearance (determined by MDRD) of <30 mL/min.
- •7. History of seizures.
- •8. History or presence of an abnormal ECG, including, but not limited to, complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the investigator*s opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
- •9. A QTcF value >450 msec or QRS >120 msec demonstrated by at least two ECGs more than 30 minutes apart.
- •10. Hemoglobin level <7.5 mmol/L.
- •11. Any blood or plasma donation or other loss of blood greater than 500 mL within 3 months of screening.
- •12. Participation in any other investigational drug study within 90 days of first study drug administration.
- •13. Use of any prescription within 7 days or 5 half-lives (whichever is longer) of the first dose administration and anticipated use through the follow-up visit.
- •14. Use of any over-the-counter medication (including vitamin/mineral supplements, and herbal medicines such as St. John's Wort) within 7 days of the first dose administration and anticipated use through the follow-up visit.
- •15. Any surgical or medical condition possibly affecting drug absorption (e.g., gastrectomy).
- •16. Poor peripheral venous access.
- •17. Alcohol, caffeine, and grapefruit consumption within 48 h before dosing.
- •18. Average daily caffeine intake greater than 450 mg / day (equivalent to 4 cups per day) from screening onwards through follow-up.
- •19. History of alcoholism, drug abuse, or drug addiction in the last 2 years.
- •20. Positive drug or alcohol test.
- •21. Use of tobacco or nicotine products within the previous month before the first dose administration.
- •22. Positive serology for HBV, HCV, or HIV by HIV1 and HIV2 antibodies, Hepatitis B antigen or Hepatitis C antibodies.
- •23. Subjects who are part of the clinical staff personnel or family members of the clinical site staff.
- •24. Any other issue which, in the opinion of the Investigator, will make the subject ineligible for study participation.
- •25. Food Effect Cohort: Subjects who are unwilling to consume the required high fat test meal.
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