A Phase 2, Randomized, Unicentric Clinical Trial With Dose Scaling for Safety, Tolerability and Efficacy Assessment of 18-Methoxycoronaridine Administered to Cutaneous Leishmaniasis Patients

Infan Industria Quimica Farmaceutica Nacional0 个研究点目标入组 52 人开始时间: 2021年5月最近更新: 2020年3月19日

适应症

干预措施

试验速览

阶段: 2 期
发起方
入组人数: 52
主要终点: Lesion Reduction and Re-epithelization - Definitive Cure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 59 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age between 18 and 59 years of age;
•Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
•Parasitological confirmation;
•Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
•Men and women should use barrier contraceptive methods during the course of the study;

排除标准

•History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
•History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
•Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
•Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
•History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
•Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
•Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
•Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
•History of cancer;
•History of drug abuse, judging by the investigator
•History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
•History of smoking
•History of severe allergy / hypersensitivity, judged by the investigator;
•History of hypersensitivity to drugs with similar chemical structure.