KCT0001470已完成未知
A Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of EC-18 after oral administration in healthy male volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 64
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 45(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
- •2) Body weight = 50 kg, and calculated BMI in the range of 18.5 kg/m2 = BMI < 25.0 kg/m2
- •? BMI(body mass index) = Body weight (kg)/[height (m)]2
- •3) No inherited or chronic disease and pathologic symptoms or findings from internal examinations
- •4) Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug
- •5) Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial
- •6) Consent to practice medically acceptable contraception during the trial
排除标准
- •1) Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity
- •2) Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records
- •3) Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records
- •4) Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history
- •5) (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis
- •6) Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption,
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