Administration of CIGB500 in healthy volunteers. Phase I study on scaling up dosages.

Center for Genetic Engineering and Biotechnology (CIGB), Havana City0 个研究点目标入组 18 人开始时间: 2010年12月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Other

•Male individuals of 18 to 35 years of age. Absence of important clinical signs during the interrogation and in the physical examination. Normal Electrocardiogram. Analysis of hematology, plasmatic biochemistry and urine within the normal limits. Normal body weight according to height. Willingness of the individual shown by signing the written consent.

•History of endocrine-metabolic alterations. History of significant acute diseases in the last 30 days. History of chronic diseases (cardiovascular, respiratory, neurological, renal, respiratory, gastrointestinal, liver or hematological diseases). Administration of a pharmaceutical under study within 45 of having entered the study. Use of some medicine within 15 days before having entered the study. Donation or loss of blood greater than 400 mL within 12 weeks before entering the study. Severe adverse reactions or hypersensitivity to a drug. History of alcoholism or alcohol consumption within 24 before the administration of the drug. Consuming more than 10 cigarettes a day.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), Havana City