KCT0007215已完成未知
A Randomized,Open-Label or Double-Blind, Placebo-Controlled, Single and Multiple Dosing, Dose-Escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmakokinetic/Pharmakodynamic characteristics, Food Effect after Oral Administration of HSG4112 in Healthy Subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Glaceum
- 入组人数
- 36
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) Adults between 19 and 50 years of age at screening.
- •3) Body mass index (BMI) between 18 and 24.9.
- •? BMI (kg/m2) = Body 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 test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
- •5) For Part 2 (i.e., the multiple dose study), female subjects who have regular menstrual cycles(28±7 days) and who are not pregnant or lactating.
排除标准
- •1) Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-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-containing drugs, aspirin, antibiotics).
- •4) One or more of the following laboratory test results at screening:
- •- ALT (SGPT) > 60 IU/L
- •- Glucose (fasting) > 110 mg/dL or < 70 mg/dL
- •5) Systolic blood pressure of < 90 mmHg or > 150 mmHg, or diastolic blood pressure of < 60 mmHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
- •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 within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
- •8) Participation in any clinical study or bioequivalence study involving the administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
- •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) Smoker. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
- •11) Alcohol consumption of > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period, starting from 3 days prior to dosing.
- •12) Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, 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 (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
- •14) Unable or unwilling to use acceptable contraceptive methods for themselves or their spouse/partner during the entire study period and up to 28 days after the last dosing and subjects who satisfy at least one of the pregnancy-related criteria below:
- •- Females of childbearing potential who plan to use hormonal contraceptives or oral contraceptives during the study period
- •- Females of childbearing potential confirmed positive in a pregnancy test
- •**Females of childbearing potential refer to females who have experienced menarche and have not undergone a successful surgical sterilization procedure (i.e., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy) or is not menopause (i.e., 12 months without menstruation).
- •***Acceptable contraceptive methods include:
- •- Use of an intrauterine device, which has been proven highly effective.
- •- Physical contraception for subject or
研究者
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