ACTRN12620000572965已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled StudyTo Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Ascending Doses Of AUM001 In Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
one
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1) Male or female, light smokers, greater than or equal to 18 and less than or equal to 50 years of age, with BMI greater than 18.5 and less than 30.0 kg/m2 and body weight greater than or equal to 50.0 kg for males and less than or equal to 45.0 kg for females.
- •2) Female subjects must be non-pregnant, non-lactating, postmenopausal for at least 1 year, surgically sterile, or agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after Study Completion. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use one of the following acceptable contraceptive:
- •3) Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
- •4) Male subjects with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration.
- •5) Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- •6) Subjects will be required to read, understand, and sign the informed consent and will be able to spend the days specified in the study schedule confined in a facility under study rules.
- •7) Subjects will have no history of cardiac disease.
- •8) Each subject’s baseline Safety Laboratory Assessment values must have no clinically significant abnormalities. This includes hematology, clinical chemistry, and urine analysis.
- •9) Subjects must be healthy volunteers with no active or chronic diseases/disorders,
- •10) Subjects will not have any allergy to the test article or to the constituents of the capsules
排除标准
- •1) Women who are nursing or pregnant.
- •2) Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
- •3) Acute disease state
- •4) Admitted alcohol abuse or consumption of more than 2 standard units per day in the last 6 months.
- •5) Any clinically important deviation from normal limits in physical examination, vital signs, or clinical laboratory test results.
- •6) Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or HCV antibodies.
- •7) Positive urine drug screen or alcohol test
- •8) History of allergy to any component of the test article.
- •9) Use of any prescription drug within 30 days prior to first dosing.
- •10) Use of any over-the-counter drugs including herbal supplements and Traditional Chinese Medicines within 14 days prior to first dosing.
- •11) Diets that alter metabolism
- •12) Participation in another clinical trial within 3 months prior to first dosing.
研究者
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