ISRCTN64317949已完成1 期
A phase 1, single center, placebo-controlled, interventional study to evaluate the safety, tolerability, and pharmacokinetic profiles in healthy subjects compared to placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- 性别
- All
入选标准
- •1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
- •2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening
- •3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia [e.g., Gilbert’s syndrome] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee)
- •4. Female subjects will be non-pregnant and non-lactating
- •5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions
排除标准
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (i.e., a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check-in until 90 days after the Follow-up Visit
- •2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e., a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow-up Visit. a. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
- •3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
- •4. Subjects with serum creatinine >ULN
- •5. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
- •6. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
- •7. Alcohol consumption of >28 units per week for males and >21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits
- •8. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check-in
- •9. Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator
- •10. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half-lives, whichever is longer) prior to Check-in
- •11. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks, or chocolates (>8 cups of coffee or equivalent per day)
- •12. Consumption of food or drinks containing poppy seeds, grapefruit, or Seville oranges from 7 days prior to Screening
- •13. Use, or intend to use, any prescription medications/products other than oral, implantable, transdermal, injectable, or intrauterine contraceptives, or hormone replacement therapy, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
- •14. Use, or intend to use, slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
- •15. Use, or intend to use, any non-prescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
- •16. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in
- •17. Receipt of blood products within 2 months prior to Check-in
- •18. Donation of blood
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