NCT02243683已完成1 期
A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl 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
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious and Non-Serious Adverse Events
研究概览
简要总结
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]
- •In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- •Subject with no history of autoimmune disease or cardiac disease
- •Subjects must be available to complete the study (including follow-up visit).
- •Subjects must satisfy a medical examiner about their fitness to participate in the study.
- •Subjects must provide written informed consent to participate in the study.
排除标准
- •A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- •Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
- •A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
- •A clinically significant history of drug or alcohol abuse.
- •Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
研究组 & 干预措施
Cohort B
Experimental
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
干预措施: Placebo (Other)
Cohort A
Experimental
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
干预措施: AX-024.HCl (Drug)
Cohort A
Experimental
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
干预措施: Placebo (Other)
Cohort B
Experimental
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
干预措施: AX-024.HCl (Drug)
结局指标
主要结局
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: Over a 72 hours period and 7 days after last dose
次要结局
- Area Under the Concentration-Time Curve(Over a 72 hours period post dose)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Safety and Pharmacokinetics Study of a New Drug for Type 2 DiabetesHealthyNCT02686281Genmedica Therapeutics S.L.19
已完成
1 期
A Study of the Safety and Tolerability of GWP42006 in Healthy SubjectsEpilepsyNCT01918735Jazz Pharmaceuticals66
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy VolunteersHealthy VolunteerNCT03645746Regeneron Pharmaceuticals56
终止
1 期
Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy VolunteersHealthy VolunteerNCT04616079Regeneron Pharmaceuticals57
已完成
1 期
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477Healthy VolunteersNCT02870400Regeneron Pharmaceuticals41