A Dose Selection Phase 1 Study Evaluating the Safety and Tolerability of Silmitasertib
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAT)
研究概览
简要总结
This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.
详细描述
COVID-19 is characterized by SARS-CoV-2 induced up-regulation of host protein kinase CK2 that catalyzes phosphorylation of many proteins, modulating their activities in cellular processes. CX-4945 demonstrated anti-viral efficacy in COVID-19 in vitro studies. In CX4945-AV01-IIT(IND 152726), CX-4945 was a safe treatment at 1000 mg BID regimen supported by the fact of no occurrence of treatment related Grade ≥ 3 AE, death or SUSAR. There were approximately 50 % of patients who experienced gastrointestinal disorders of grade 1-2. In CX4945-AV01-IIT, an out-patient study, there were 50% experienced gastrointestinal disorders. To further evaluate the safety and tolerability of CX-4945, this phase 1 study will use lower doses and subjects will be close-monitored to evaluate the safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects 20to 55 years of age, inclusive, at screening
- •Body mass index (BMI)within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
- •Subjects who are of reproductive potential agreed to remain abstinent or use (or have their partner use) an acceptable method of birth control (intrauterine device, hormonal contraception, vasectomy or condom) from screening until at least 2 weeks after the last study drug administration.
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
- •Subject with acceptable hematology, biochemistry and urinalysis during screening period.
- •Subject is willing and able to comply with study procedures and sign informed consent.
排除标准
- •Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and from screening until at least 2 weeks after the last study drug administration. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
- •Active or uncontrolled infections such asCOVID-19, HIV or with serious illnesses or medical conditions which would not permit the subject to receive study treatment.
- •Subject has received any prescription of drug within 3 days prior to study enrollment.
- •Subject has drug abuse history.
- •Any active or recurring clinically significant hepatic disease including HBV and HCV.
- •Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
- •Any other medical reason as determined by the investigator.
研究组 & 干预措施
CX-4945 200mg QD
CX-4945 will be administered at 200mg QD for continuously 5 days.
干预措施: CX-4945 (Drug)
CX-4945 200mg BID
CX-4945 will be administered at 200mg BID for continuously 5 days.
干预措施: CX-4945 (Drug)
CX-4945 400mg BID
CX-4945 will be administered at 400mg BID for continuously 5 days.
干预措施: CX-4945 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAT)
时间窗: Day 1 to Day 5
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity \[as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0\], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
次要结局
- Evaluate Changes in Blood Chemistry.(Day 1 to Day 6)
- To Evaluate Changes in Blood Chemistry.(Day 1 to Day 6)
- Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG(Screening, Day 1, Day 3, Day 5, and Day 6)