Phase I, Monocentric, Double-blind, Randomized Study to Assess Tolerability, Safety and Pharmacokinetics of ACH15 After Single Dose and Multiple Doses in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is evaluate the safety and tolerability parameters regarding the new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and multiple doses of the new drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patient, aged between 18 and 50 years;
- •Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2;
- •Healthy men accordance with their historical and tests;
- •Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol
- •Negative results for parasitological stool examination performed in the clinical study;
- •Subject of research with laboratory results within the normal range for urinalysis collected before the first visit;
- •Research subjects allocated in Group 6 with endoscopy within the normal range;
排除标准
- •History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma;
- •Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality;
- •History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study;
- •Use of any medication two (2) weeks prior to inclusion of the research subject in the study;
- •Regular smokers or who quit less than one (1) year;
- •History of food allergy or hyperreactivity to medications or foods;
- •HIV positive for HIV;
- •Being positive for Hepatitis B;
- •Being positive for hepatitis C;
- •Testing positive for Helicobacter pilorum;
- •Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form);
- •Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form;
- •Subject with a history of hypersensitivity to any component of the investigational product;
研究组 & 干预措施
ACH15 - 500mg capsule
ACH15 500mg capsule by mouth in a single dose(Group 3)
干预措施: ACH15 500mg (Drug)
ACH15 - 50mg capsule
ACH15 50mg capsule by mouth single dose (Group 1)
干预措施: ACH15 50 mg (Drug)
ACH15 - 250 mg capsule
ACH15 250mg capsule by mouth as single dose(Group 2)
干预措施: ACH15 250 mg (Drug)
ACH15 - 1000 mg (two 500mg capsule)
ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
干预措施: ACH15 - 1000mg (Drug)
ACH15 - 2000 mg (four 500 mg capsule)
ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
干预措施: ACH15 - 2000mg (Drug)
ACH15 - 500 mg (twice a day for 7 days)
ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
干预措施: ACH15 - 500mg (Drug)
Placebo - 250 mg capsule
Placebo 250mg capsule by mouth single dose (Group 2)
干预措施: Placebo 250 mg (Drug)
Placebo - 500 mg capsule
Placebo 500mg capsule by mouth in a single dose(Group 3)
干预措施: Placebo 500mg (Drug)
Placebo - 1000 mg (two 500mg capsule)
Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
干预措施: Placebo 1000mg (Drug)
Placebo 2000 mg (four 500mg capsule)
Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
干预措施: Placebo 2000mg (Drug)
Placebo - 500 mg (twice a day for 7 days)
Placebo 500mg capsule by mouth twice a day for seven days (Group 7)
干预措施: Placebo 500mg (Drug)
结局指标
主要结局
Cmax
时间窗: 67 pint time over 8 days
Blood analysis to evaluate drug pharmacokinetics at Group 6:00:30 min before dose, 00h20min, 00h40min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06h, 08h, 10h, 12h, 14h, 18h, 24h, 26h, 30h, 36h, 38h, 42h, 48h, 50h, 54h, 60h, 62h, 66h, 72h, 74h, 78h, 84h, 86h, 90h, 96h, 98h, 102h, 108h, 110h, 114h, 120h, 122h, 126h, 132h, 134h, 138h, 144h, 146h, 150h, 156h, 158h, 162h, 168h, 174h, 180h e 192h post-dose.
High digestive endoscopy (participants included at Group 6)
时间窗: 8 days
Image exam to evaluate the drug safety
Echocardiography (participants included in Group 6)
时间窗: 30 days
Blood pressure
时间窗: 30 days
Electrocardiogram
时间窗: 30 days
Blood analysis
时间窗: 30 days
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
次要结局
未报告次要终点