A Phase I, Double-blind, Randomized, Placebo-controlled, Single-Dose Escalation, First-in-human Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SKI2670
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.
详细描述
In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects.
Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 20 years of age and older
- •Weight between 40kg~70kg
- •Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing
- •A history of regular menstrual cycles (cycle: 28±7day, duration: 2~7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of IP(investigational product) dosing
排除标准
- •Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding
- •A history of breast cancer, genital cancer or any estrogen dependent tumor
- •Specified or unspecified diagnosed infertility or history of natural abortion over three times
- •A history of taking other Investigational product within 60days before screening visit or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter drugs) within 14days before screening visit
- •Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia
- •AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal
- •QTc > 450ms on electrocardiogram result
研究组 & 干预措施
SKI2670
Single-dose escalation/ Subjects received an oral single dose of SKI2670 capsule by dosing group
-Dosing Group 1, Dosing Group 2, Dosing Group 3, Dosing Group 4
干预措施: SKI2670 (Drug)
Placebo
Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: From day 1 to day 16~26D after a single oral dose.
All participants who ever were administered with investigational product are assessed.
次要结局
- Peak Plasma Concentration (Cmax) of SKI2670(0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h)
- Area Under Curve (AUC) of SKI2670(0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h)
- Concentration Change from Baseline(%) of Luteinizing Hormone (LH)(day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D)