NCT01633723已完成1 期
A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male 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
- 105
- 试验地点
- 1
- 主要终点
- Assessment of safety
研究概览
简要总结
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20 ~ 45 years old
- •27kg/m2 ≥ BMI ≥ 20kg/m2
- •Healthy Male
- •Informed consent
排除标准
- •Clinically significant medical history
- •Clinically significant hypersensitivity of Drugs
- •Clinically significant cutaneous disorder
- •QTcB > 450msec
- •have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
研究组 & 干预措施
DA-6886
Experimental
干预措施: DA-6886 (Drug)
DA-6886 placebo
Placebo Comparator
干预措施: Placebo of DA-6886 (Drug)
结局指标
主要结局
Assessment of safety
时间窗: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG
次要结局
- Pharmacokinetics and Pharmacodynamics(up to 48 hours after last dosing of DA-6886)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder PeopleAlzheimer DiseaseNCT06367426Pharmacobio100
已完成
1 期
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian SubjectsHealthyNCT00785915AstraZeneca40
已完成
1 期
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese SubjectsHealthyNCT01114152AstraZeneca35
已完成
1 期
A Study of STSA-1201 in Healthy SubjectsHealthyNCT05986877Staidson (Beijing) Biopharmaceuticals Co., Ltd44
已完成
1 期
Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy VolunteersHealthy VolunteersNCT01980615Pearl Therapeutics, Inc.84