ACTRN12624000245594招募中1 期
A Phase I, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of XG2002 Oral Administration in Healthy Adult Volunteers
Xgene Pharmaceutical Pty Ltd0 个研究点目标入组 32 人开始时间: 2024年3月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female volunteers between 18 and 65 years of age, inclusive (at the
- •time of ICF).
- •2. Weight greater than or equal to 60 kg and a Body Mass Index (BMI) 18.0 to 35.0 kg/m2, inclusive.
- •3. Medically healthy, with no clinically significant medical conditions in the opinion of the Investigator.
- •4. Able to comprehend and provide voluntarily signed informed consent form, and to abide by the study restrictions and requirements.
- •5. Non-pregnant, non-breastfeeding female subjects may be enrolled if they are:
- •a. Surgically sterilized (verbal confirmation acceptable) or postmenopausal
- •(amenorrhea greater than or equal to 1 year and follicle-stimulating hormone greater than or equal to 30 mU/mL); or
- •b. Practicing true abstinence or an effective method of contraception from Screening visit until 3 months following the last dose of study drug, and must have a negative serum pregnancy test (women of childbearing potential [WOCBP] only) at screening and a negative urine pregnancy test (WOCBP only) on Day -1.
- •6. Male subjects may be enrolled if they are:
- •a. Surgically sterilized (vasectomy – verbal confirmation acceptable); or
- •b. Practicing true abstinence from Screening visit until 90 days following the last dose of study drug; or
- •c. Willing to use a condom during sexual activity, plus appropriate contraceptive measures for his female partner from Screening visit until 90 days after the last dose of study drug. This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential; and
- •d. Do not donate sperm for 90 days after last dose of study drug (non- vasectomized subjects).
排除标准
- •1. Subjects with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), haematological, or psychiatric as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECGs evaluations, or in the opinion of the Investigator.
- •2. Subjects with clinically significant history of medical condition (in the opinion of the Investigator).
- •3. Subjects with any report of acute illness or febrile event that has not been resolved within 72 hours prior to dosing.
- •4. Subjects with any of the following laboratory test results at Screening:
- •a. creatinine clearance < 90 mL/min (estimated using the Cockcroft and Gault equation)
- •b. elevation of liver function tests: ALT, AST, GGT, bilirubin, or alkaline phosphatase > 1.5 times of the upper limit of normal range
- •c. leucocytes or lymphocytes < 1.5 times of the lower limit of normal
- •d. hemoglobin < the normal range of corresponding gender
- •5. Subjects with positive results for hepatitis B surface antigen (HbsAg) and/or hepatitis B anticore antibody (anti-HBc) but negative results for anti-surface antibody (antiHBs) at Screening visit
- •6. Positive results for hepatitis C antibody unless patient received curative therapy and a negative viral load is documented.
- •7. Human immunodeficiency virus (HIV) infection or positive HIV serology at the Screening Visit.
- •8. Subjects who have smoked more than 5 tobacco or nicotine-containing product (including nicotine patches) per week for 90 days prior to screening through to the end of the study.
- •9. Positive urine drug screen at Screening and Day -1, or positive alcohol breath test on Day -1.
- •10. Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to drug administration, or plan to consume them through the completion of the follow-up visit.
- •11. Sleep pills 3 days prior to randomization and for the duration of the study
- •12. Unless a specific dietary need can be catered for at the study site, subjects with an abnormal diet including lactose/gluten intolerance, food rich with capsaicin or causing dysgeusia or other dietary restrictions (except vegetarian/vegan or religious dietary requirements), as determined by the Investigator 30 days prior to the study dosing.
- •13. Subjects with a history of donation of blood or blood products, or significant blood loss (>480ml) within 30 days prior to the study dosing.
- •14. Participation in another clinical trial with medicinal intervention within 30 days or 5 half-lived, whichever is longer, prior to the study dose.
- •15. Known or suspected hypersensitivity or idiosyncratic reaction to the study drug or its excipient.
研究者
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