A Double-Blind, Placebo Controlled, Single Dosing, Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, PK/PD of J2H-1702 After Oral Administration in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
- Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects.
详细描述
- Study Methodology: 6 Subjects will be randomized to the study group (J2H-1702 group) and 2 subjects will be to the placebo group. AE, VS, ECG, Lab tests will be evaluated to check the safety, tolerability and PK/PD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females aged ≥ 19 and ≤ 45 years
- •Subjects with a body mass index (BMI) ≥ 18.0 to ≤ 27.0 kg/m2
- •Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests
- •Agree to use dual contraceptive methods and not to donate eggs
- •Voluntarily agree to participate in the study
排除标准
- •A subject who had or has the disease corresponding to clinically significant liver, etc.
- •A subject with a history of gastrointestinal diseases or surgery
- •A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
- •A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
- •One who has drug abuse and one who is positive response in urine drug screening tests
- •A subject with abnormal vital signs at the screening visit
- •A subject who has participated in another clinical trial or bioequivalence test
- •A subject who donated whole blood or the ingredient, or received blood transfusion
- •A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
- •A subject who consumes grapefruit/caffeine-containing food
- •A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
- •High caffeine intaker, high alcohol intaker or excessive smoker
- •A subject who cannot eat meals provided by the Clinical Trial institution.
- •A subject who participated in this trial and were administered the investigational product.
- •A subject who is positive for serum test
- •A pregnant or breast-feeding subject
- •A subject who the investigator deems inappropriate for this clinical trial
研究组 & 干预措施
Amg dose Group
Amg dose administration group
干预措施: Amg dose administration group (Drug)
Amg dose Group- Placebo
Amg dose administration group- Placebo
干预措施: Amg dose administration group- Placebo (Drug)
Bmg dose Group
Bmg dose administration group
干预措施: Bmg dose administration group (Drug)
Bmg dose Group- Placebo
Bmg dose administration group- Placebo
干预措施: Bmg dose administration group- Placebo (Drug)
结局指标
主要结局
Cmax
时间窗: 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours (After IP administration)
Pharmacokinetics
Emax
时间窗: -1day 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours, 1day 0 (Before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours (After IP administration)
Pharmacodynamics
次要结局
未报告次要终点