NCT02949089已完成1 期
An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
Ache Laboratorios Farmaceuticos S.A.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月最近更新:
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
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the safety of rising multiple doses of ACH04
研究概览
简要总结
This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects will be healthy males subjects between 18 and 50 years of age;
- •Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
- •Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.
排除标准
- •Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
- •Subjects who have a significant history of alcoholism or drug/chemical abuse;
- •Subjects who have body mass index < 18 or > 30;
- •Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
- •Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
- •Subjects who were hospitalized for any reason in the six week prior the study start;
- •Subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol;
- •Subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year;
- •Subjects who are relatives of employees from the sponsor and the site, respectively;
- •Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator;
- •Any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.
研究组 & 干预措施
ACH04
Experimental
Dosage: 1 capsule, PO, 24/24h for 10 days.
干预措施: ACH04 (Drug)
结局指标
主要结局
Evaluate the safety of rising multiple doses of ACH04
时间窗: up to 39 days
Evaluate the occurrence of adverse events, Assess safety through laboratory tests and Assess safety through electrocardiogram
次要结局
未报告次要终点
研究者
研究点 (1)
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