Phase I study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative clinical trial

Eubiologics0 个研究点目标入组 20 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1) Adult men over 20years of age
•2) More than 45kg body weight and ideal body weight within ±20% of the weight
•3)Screening was conducted within 14 days of investigational drug administration (Vital Sign & Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
•4) Written consent person who determines to participate in a clinical trial

•1) A person who showed hypersensitivity when other preventive vaccination in the past
•2) A person who have received cholera vaccine in the past
•3) A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
•4) A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
•5) A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
•6) A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
•7) A person who received other preventive vaccine within 2months before the start of the experiment
•8) A person who received blood products of immune globulin preparatios within 3months before the start of the experiment
•9) A person who has immune function disorders or are receiving immunosuppressive treatment
•10) A person who has chronic illness in progress
•11) Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
•12) A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
•13) A person who is difficult to participate in this clinical trials as the discretion of the investigator

发起方

Eubiologics