KCT0002773已完成未知
A Prospective, Dose-block Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, and Pharmacodynamics of Subcutaneous Administration of EG-Myocin Concomitantly with Oral Coadministration of Clopidogrel and Aspirin in healthy Male Volunteers
Eyegene0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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. Subjects who voluntarily decided to participate and have consented after hearing about this clinical study and investigational product.
- •2. Healthy adult males aged between 19 and 45 (at the time of screening)
- •3. Body weight 55kg or above (BMI between 19(inclusive) and 27(exclusive))
- •4. If screening tests clearly show that a person who is judged to be suitable for this clinical test (even if the results of the physical examination, laboratory test, imaging, ECG are outside the normal range, and if there is a clear rational for participation based in the principle investigator’s judgement, the volunteer may be included).
排除标准
- •1)Presence of diseases or anamnesis (hepatobiliary, kidney, nervous system (central or peripheral), respiratory system, endocrine system (diabetes, hyperlipidemia, etc), circulatory system (congestive heart failure, coronary artery disease, myocardial infarction, etc), blood•tumor, urinary system, psychological, musculoskeletal system, immune system (rheumatoid arthritis, systemic lupus erythematosus, etc), ENT system) determined by investigator to be clinically significant and unable to participate in clinical study and including of the following.
- •?Bleeding patient (a peptic ulcer, intracranial hemorrhage, hemophilia, gastrointestinal bleeding, urethrorrhagia, hemoptysis, haemorrhagia corporis vitrei, etc)
- •?Severe liver disorders
- •? Severe renal disorders
- •2)Subjects at increased risk of bleeding due to trauma, surgery or other pathological conditions or with a history of hemorrhagic symptoms. (ex, ulorrhagia, hemostatic abnormality, bruising easily, etc)
- •3)Subjects who have indicated the following clinical anomalies during screening
- •-The AST or ALT values are 1.25 times higher than the normal range upper limit.
- •-The total bilirubin values are 1.5 times higher than the normal range upper limit.
- •-The PT, aPTT values are out of the normal range.
- •4)Glucose-6-phosphate dehydrogenase(G6PD) deficient patient
- •5)Subjects who cannot maintain effective contraceptive measure for 3 months from the time of the clinical study and the date of the last injection.
- •6)Subjectswho has included blood pressure in the vital signs measured in the seated position after a rest for 3 min or more, systolic pressure = 140 mmHg or =90 mmHg, minimal blood pressure=95 mmHg or =50 mmHg
- •7)An arrhythmia patient who has clinically significant ECG result.
- •8)Subjectswith an active infection or who has had fever symptoms of 38? or greater 1 week prior to administration of investigational product.
- •9)HBV or HCV infected patient or evidence of HIV infection.
- •10)Medical history of malignant carcinoma within past 3 years excluding basal cell or squamous cell carcinoma of skin, CIN and CIS of cervix, intraepithelial carcinoma of other site.
- •11)Subjects who have hypersensitivity reaction anamnesis for components (API, mannitol, etc) of Investigational Product.
- •12)Subjectswho have hypersensitivity reaction anamnesis for combined drug, salicylic acid (or clopidogrel) or its components.
- •13)Subjects who have anamnesis for aspirin-induced asthma.
- •14)Subjects who have used contraindicated medication prior to the clinical study or have received medical treatment and the required time has not elapsed
- •15)Subjects who are using contraindicated medications
- •16)Subjectswho have lost more than 400ml of blood or blood donation within 8 weeks before Investigational Product injection.
- •17)A smoker on average daily, over 10 cigarettes, in the past 3 months.
- •18)Subjects who continue to drink alcohol (21 units/week over, 1 unit = 10g of pure alcohol) or stop drinking during the clinical study.
- •19)An anamnesis person who abused alcohol and drug 6 months before screening.
- •20)A person who has dependently experienced at psychotomimetic agent and narcotic analgesic within 6 months before screening.
- •21)Patient with psychiatric or other central nervous system diseases that PI have determined to be difficult to conduct for clinical study.
- •22)Inability to communicate.
- •23)Subject who lacks an attitude or understanding of the contents of a clinical study (person who is not willing
研究者
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