A prospective, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the safety and tolerability of single and multiple doses of APRG64 in healthy adults

GENENCELL CO LTD1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2021年11月6日最近更新: 2021年10月18日

试验速览

阶段: 不适用
状态: 已完成
发起方: GENENCELL CO LTD
入组人数: 40
试验地点: 1
主要终点: 3.Physical examination (body examination, height, weight and BMI)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a Randomized, double-blind, and placebo-controlled study. Subjects will be administered one, two, or three tablets as per the assigned Cohort. Study will be conducted in 2 phase: SAD and MAD.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 20.00 Year(s) 至 45.00 Year(s)（—）
性别: Male

入选标准

•1.Healthy adult males aged
•45 years (both inclusive) of age during the time of screening. (Medically healthy without clinically significant abnormalities at the screening visit). 2.Subject who has body weight â‰¥ 60 kg where the weight shall be within Â± 20% of the ideal body weight range considering the height of the subject himself. 3.Those who agree to use appropriate contraception and not to donate the sperm during the clinical study period and up to 3 months after the end of the study. 4.Participate voluntarily after listening to the detailed explanation of this clinical trial and fully understand it, and give a written agreement with the cautions of the subject during the clinical trial period.

排除标准

•1.Self- reported history or presence of significant hepatic, renal, neurological, endocrine, hematological, tumor, urinary, cardiovascular, musculoskeletal, and mental diseases, gastrointestinal diseases or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of IP, chronic Hepatitis type B and C, Genetic problems with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
•2.Documented hypersensitivity reaction or anaphylaxis to IP 3.Unfit for screening through a medical examination.
•4.Laboratory test results showing Hemoglobin (Hb) more than 13.0 g/dL, AST or ALT more than 3 times of the NUL,total bilirubin more than 1.5 times of NUL,CPK more than 1.5 times of NUL, Estimated Glomerular Filtration Rate less than 60 mL/min/1.73 m2 6.BP outside normal range, a person with a QTcB interval greater than 450ms in a 12-lead ECG test.
•7.The use of any medication, alcohol, or drug abuse by urine drug test.
•8.Excessive intake of caffeine and alcohol, smoker 9.Received IP from other clinical research study within 90 days prior to administration of IP.
•Take drugs inducing or inhibiting IP metabolic enzymes.
•11.Donated whole blood 60 days prior to administration of IP, or donated component blood within 30 days prior to administration of IP.
•12.Consumed grapefruit-containing food within 14 days prior to administration of IP.
•13.Consumed any special medicine or herbal medicine that may affect the characteristics of IP within two weeks prior to the first administration date, or taken Over-the-counter drug (OTC) or vitamin supplements within one week prior to the first administration date.
•14.Unable to cooperate fully with the requirements of the study protocol.
•15.Those who were judged to be ineligible for participation in the clinical study by the investigator due to other reasons.