ACTRN12622001507774尚未招募1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of ACT004 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 82
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 55 Years（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects, 18-55 years of age (both inclusive) at the time of screening.
- •2.Subjects able to provide a signed and dated informed consent and/or assent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.
- •3.Subjects who agree to comply with protocol restrictions, including refraining from consuming alcohol, caffeinated beverages (e.g., tea, coffee, etc.), and tobacco or nicotine containing products from 24 hours before Day 1 until the last PK blood sample collection is finished; able to remain in house for the confinement period of the study without interruption.
- •4.Body mass index (BMI, weight [kg]/height2 [m2]) within 18.0-28.0 kg/m2 (both inclusive).
- •5.A female participant is eligible to participate if she is not pregnant and intending to become pregnant or breastfeeding, and at least one of the following conditions applies:
- •- surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year, defined as amenorrhea for 12 consecutive months without another cause and with a follicle stimulating hormone (FSH) level greater than or equal to 40 mIU/mL at screening.
- •- a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of less than 1%, during the treatment period and for at least 1 month after the last dose of study treatment.
- •6.Male subjects must be willing to remain abstinent (when this is in line with their preferred and usual lifestyle), or, if engaging in sexual intercourse with a female partner of childbearing potential, willing to use a condom in addition to having the female partner use a highly effective method of female contraception from the time of the first study drug administration until 30 days following the last dose of study drug. This requirement does not apply to subjects in a same-sex relationship, subjects with female partners of non-childbearing potentials, or vasectomized subjects who have not undergone any reversal procedure. Male subjects must also be willing to not donate sperms from the time of the first study drug administration until 30 days after the last dose of study drug.
- •7.No clinically significant abnormal values on vital signs, B-ultrasound and 12-lead ECG. QT interval corrected for heart rate according to Fridericia's formula (QTcF) must be within the following ranges: QTcF less than or equal to 450 msec for male subjects, and QTcF less than or equal to 470 msec for female subject. Assessment may be repeated once if deemed appropriate by the Investigator.
- •8.No clinically significant abnormal findings noted during screening for medical history and physical examination, or clinically significant abnormal results during screening clinical laboratory tests, including white blood cells (WBCs), liver function and kidney function. Assessment may be repeated once if deemed appropriate by the Investigator.
- •9.Negative urine drug screen and alcohol breath testing at screening and on Day -1.
- •10.Ability to swallow all study drugs.
排除标准
- •1.Subjects who have a clinically relevant intolerance or allergy to drugs, or are known or suspected to have hypersensitivity to any ingredient in the study drugs;
- •2.History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs;
- •3.History or clinical manifestations of any clinically significant gastrointestinal, renal, urologic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder or cancer, at the discretion of the Investigator;
- •4.Current or chronic history of liver disease or known hepatic or biliary abnormalities, including ALT, aspartate aminotransferase (AST), alkaline phosphatase and bilirubin greater than upper limit of normal (ULN);
- •5.Current or history of clinically significant cardiac arrhythmias (symptomatic or asymptomatic);
- •6.Subjects who have had any significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration. Subjects with a mild upper respiratory infection may be enrolled at the discretion of the Investigator;
- •7.Creatinine clearance less than 90 mL/min (using the Cockcroft-Gault method based on serum creatine and actual body weight) at screening;
- •8.Major illness or surgery (except for minor outpatient surgery) within past 3 months of study Day 1, or planned surgery during the study period;
- •9.Intolerance to direct venepuncture;
- •10.Participation in any clinical study with an investigational drug, biologic or device within 4 weeks or 5 times the half-life of the specific product if applicable (whichever is longer) since the last dosing or the last use of the investigation drug, biologic or device, prior to the first dosing of ACT004;
- •11.Donated blood greater than 400 mL or significant blood loss equivalent to 400 mL, or received blood transfusion within 1 months of screening, or have plans to donate blood during the study;
- •12.History of malignancy within 5 years of screening visit (excluding non-melanoma skin cancer that has been resected);
- •13.Positive test at screening of any of the following: serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV RNA or HCV Ab) or human immunodeficiency virus 1 and 2 (HIV Ab);
- •14.Recent administration or plans to receive administration of any live vaccine within 12 weeks before Day 1;
- •15.Use of any other drug, including prescription and over-the-counter medications, within one week of first dosing or within 5 times the elimination half-life of the medication (whichever is longer) prior to first dosing. Exceptions may be made on a case-by-case basis following discussion and agreement between the Investigator and the sponsor.
- •-Paracetamol at a dose of less than 2 g in 24 hours but no more than 1 g in 4 hours is permitted;
- •-Dietary vitamins may be allowed at the discretion of the Investigator (e.g., vitamin D taken at a standard replacement dose and at a time remote from IP administration);
- •-Herbal supplements are not permitted;
- •16.Unwilling to refrain from caffeinated beverages (i.e., tea, coffee, etc.) from 24 hours before Day -1 until completion of the confinement period;
- •17.Use of food or beverages likely to influence liver metabolism or inhibit CYP2C9, within 14 days prior to the first dose of the study drug (e.g., star fruit, pomelos, grapefruit & Seville oranges);
研究者
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