ACTRN12619000327189已完成1 期
A Phase 1, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of SM07883, a Novel DYRK1a Inhibitor, Following Oral Administration to Healthy Subjects
Samumed Pacific Pty Ltd0 个研究点目标入组 28 人开始时间: 2019年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Healthy adult females 18 to 70 years old; or, healthy adult males 18 to 70 years old, who are surgically sterile; or, healthy adult males greater than 55 years old with no interest in fathering a child in the future
- •2. Body mass index (BMI) of 19 to 30, inclusive
- •3. Subject must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed.
- •4. Willingness and ability to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures.
- •5. Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study.
排除标准
- •1. Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result
- •2. Women of childbearing potential who are sexually active, and who are not willing to use an acceptable method of birth control during the study period
- •3. Men up to 55 years old (inclusive) who are of childbearing potential
- •4. Men greater than 55 years old of childbearing potential who may wish to father a child in the future
- •5. Men greater than 55 years old of childbearing potential who are sexually active and have a partner who is capable of becoming pregnant, neither of whom are agreeable to using an acceptable method of birth control
- •6. History of or current allergy to investigational product ingredients.
- •7. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic, or dermatologic disease
- •8. History of malignancy within the last 5 years
- •9. Recent treatment with an investigational product.
- •10. History of long QT syndrome and/or clinically significant ECG
- •11. History of clinically significant increased intracranial pressure, bleeding diathesis, cardiopulmonary instability, or soft tissue infection at the proposed puncture site
- •12. Clinically significant laboratory abnormalities at Screening
- •13. Recent active infection or febrile illness
- •14. Recent serious illness requiring hospitalization
- •15. Any chronic condition that has not been well controlled. 16. Uncontrolled hypertension
- •17. Regular alcohol abuse
- •18. A history of abuse of prescription or illicit drugs
- •19. Positive urine drug screen
- •20. Recent use of strong inhibitors or inducers of CYP3A4 and CYP2D6 enzymes (eg grapefruit, grapefruit juice, and star fruit).
- •21. Subjects who have a current or pending disability claim, workers’ compensation, or litigation(s)
- •22. Subjects who are immediate family members of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site.
- •23. Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners responsible for the conduct of the study
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