KCT0007954尚未招募未知
A randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect after oral administration of HGR4113 in healthy subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- Glaceum
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •1. Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening.
- •2. 19 to 50 years, inclusive, at Screening.
- •3. BMI =18.0 but <25.0
- •? (BMI (kg/m2) = Weight (kg) / Height {(m)}2)
- •4. In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluations at Screening, or subjects whose abnormal test results have been deemed acceptable by the Investigator.
排除标准
- •1. Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, psychiatric diseases (e.g., mood disorder, compulsive disorder).
- •2. History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
- •3. Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics).
- •4. One or more of the following laboratory test results at screening:
- •- ANC <1000
- •- AST, ALT, GGT, total bilirubin is greater than 1.5x upper limit of normal
- •- Glucose (fasting) =126 mg/dL or HbA1c =6.5%
- •- eGFR <60, calculated from CKD-EPI
- •5. Systolic blood pressure of <90 mmHg or >150 mmHg, or diastolic blood pressure of <60 mgHg or >100 mmHg as determined by vital signs monitored after resting in sitting position for 3 minutes or longer.
- •6. History of drug/chemical abuse or tested positive in urine drug screen.
- •7. Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins 7 days prior to dosing, unless deemed acceptable by the Investigator.
- •8. Participation in any clinical study, including bioequivalence studies, involving administration of an investigational drug 6 months prior to dosing.
- •9. Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
- •10. Alcohol consumption of >21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
- •11. History of smoking within 90 days prior to dosing or unable or unwilling to abstain from smoking starting from 90 days prior to dosing until the last pharmacokinetic blood collection timepoint.
- •12. Ingestion of grapefruit-containing foods or beverages starting from 3 days prior to dosing until the last pharmacokinetic blood collection timepoint or unable to abstain from ingesting such foods or beverages during the same period.
- •13. Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (black tea, green tea, etc.), soft drinks, coffee milk, energy drinks, sports drinks) starting from 3 days prior to dosing until the last pharmacokinetic blood collection timepoint.
- •14. Females who have tested positive in a urine HCG test, are pregnant, or lactating before the dosing of an investigational product, excluding females who have experienced amenorrhoea for 12 months or longer or have been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy).
- •15. Unwilling, or whose partner is unwilling, to use a medically acceptable means of contraception or abstain from sperm donation during the study period and up to 90 days after the last day of dosing.
- •Medically acceptable means of contraception include:
- •- Use of an intrauterine device that has been proven highly effective by the subject or the subject's partner.
- •- Barrier contraception for males or females used with chemical sterilization
- •- Surgical sterilization of the subject or the s
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