NCT05017870已完成1 期
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001 in Healthy Male Volunteers
Kukje Pharma1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.
详细描述
After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
- •Body weight >= 50 kilogram and ideal body weight within the range ±20%.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
排除标准
- •A subject who has symptoms of suspected acute disease at the time of screening.
- •Subjects with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, musculoskeletal, immune, the nose and ears, psychiatry, stomach system.
- •A subject determined to be unsuitable as a subject through a physical examined during screening.
- •A subject who is determined to be unsuitable as a subject through an ophthalmologic examination performed during screening.
- •A subject with a history of ophthalmic surgery, trauma and chronic diseases.
- •A subject who has acute or chronic eye disease requiring the use of local eye drops at the time of screening.
- •Subjects who need to wear contact lenses during clinical trial period.
- •A subject with clinically significant allergic disease.
- •A subject with a history of drug abuse.
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
- •A subject who takes drugs that induce and inhibit drug metabolises such as barbital medicines within one month before the administration of clinical trial drugs.
- •A subject who donates blood to the whole blood within 60 days before the administration of a clinical trial drug or a person who donates blood to the component within 20 days before the administration of a clinical trial drug.
- •A subject who has taken a specialty drug or herbal medicine within 14 days of administration of a clinical trial drug or a general medicine or vitamin formulation within 7 days.
- •A subject who can not continually ingest caffeine or ingest caffeine-containing foods during the period from 24 hours to discharge from hospital.
- •A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.
- •A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.
- •A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.
研究组 & 干预措施
KSR-001-01
Experimental
Participants received KSR-001-01 for 6 days.
干预措施: KSR-001 (Drug)
KSR-001-02
Experimental
Participants received KSR-001-02 for 6 days.
干预措施: KSR-001-02 (Drug)
KSR-001-03
Experimental
Participants received KSR-001-03 for 6 days.
干预措施: KSR-001-03 (Drug)
KSR-001-04
Placebo Comparator
Participants received KSR-001-04 for 6 days.
干预措施: KSR-004 (Drug)
结局指标
主要结局
Tmax
时间窗: 6 days
Pharmacokinetic Characteristics
t1/2
时间窗: 6 days
Pharmacokinetic Characteristics
Cmax
时间窗: 6 days
Pharmacokinetic Characteristics
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult SubjectsHealthy Adult SubjectsNCT06635226IlDong Pharmaceutical Co Ltd36
终止
1 期
Multiple Ascending Dose Study in Subjects With Type 2 DiabetesDiabetes MellitusNCT01856881Amgen86
已完成
1 期
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsThrombosisNCT03197779Bristol-Myers Squibb691
已完成
1 期
An Evaluation of VR942 in Healthy Volunteers and Patients With Mild AsthmaAsthmaNCT02473939Vectura Limited85
招募中
1 期
A Study of HS-10501 Tablets in Healthy SubjectsHealthy SubjectsNCT06359600Jiangsu Hansoh Pharmaceutical Co., Ltd.84