NCT01348516已完成1 期
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of KM-023 After Oral Administration in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Safety/ Tolerability Evaluation
研究概览
简要总结
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
- •Male or female between 20 and 45 years of age at the time of screening, inclusive
- •A subject with body weight ≥ 45 kg and body mass index (BMI) between 18.5 and 25 (inclusive). - BMI (kg/m2) = weight (kg) / {height (m)}2
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
排除标准
- •A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies
- •A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
- •A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- •A female subject who is pregnant, nursing mother, or sexually active females (childbearing potential)
- •Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergot medications (e.g. Wigraine, cafergot, St. John's wort), Phenobarbitol
- •Patients who have previously demonstrated hypersensitivity to Efavirenz or to one of the components of Stocrin or Sustiva
- •A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening.
- •A positive test for HIV antibody (as per local practice)
- •A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration.
- •A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
- •A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
- •The value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than 1.25 times the upper limit of the reference range.
- •A subject who is unable to abstain from drinking alcoholic beverages throughout the study period.
- •A subject with a history of drug abuse, or a positive urine drug screening test
- •A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products
- •A subject who is unable to eat a standardized meal offered by the study center
- •A subject who will be previously assigned to treatment during this study (except those who did not take any study medications)
- •Systolic blood pressure outside the range of 80 to 140 mm Hg, or diastolic blood pressure outside the range of 60 to 85 mm Hg, or heart rate outside the range of 50 to 100 beats per minute (bpm) for females; outside and the range of 45 to 100 beats per minute (bpm) for male subjects. Blood pressure and heart rate should be taken after 10 minutes of rest.
- •The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons
研究组 & 干预措施
KM-023
Experimental
干预措施: KM-023 (Drug)
Placebo for KM-023
Placebo Comparator
干预措施: Placebo for KM-023 (Drug)
结局指标
主要结局
Safety/ Tolerability Evaluation
时间窗: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
次要结局
- Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023(participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD)
- Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023(participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Effect of KB003 in Subjects With Asthma Inadequately Controlled by CorticosteroidsModerate-to-Severe AsthmaNCT01603277Humanigen, Inc.160
Unknown
2 期
Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line TherapyGastric CancerGastroesophageal CancerNCT04555304Chengdu Kanghong Biotech Co., Ltd.81
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)Type 1 Diabetes MellitusNCT02059174Merck Sharp & Dohme LLC76
终止
2 期
Phase 2 Study of Oral K201 for Prevention of AF RecurrenceAtrial FibrillationNCT01067833Sequel Pharmaceuticals, Inc300
已完成
1 期
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)HealthyNCT01017458Merck Sharp & Dohme LLC68