jRCT2031230116已完成不适用
A randomized, dose escalating, double-blind, placebo-controlled to investigate the safety, tolerability, and efficacy of IRO-203 booster intranasal vaccination in healthy volunteers who have been COVID-19 vaccinated, phase 1 study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects aged over 18 at the time of obtaining informed consent.
- •Subjects who can comply with the requirements and restrictions described in this protocol, visit the hospital at the prescribed time, and undergo necessary tests, etc.
- •Subjects who have received two or more other new coronavirus vaccines in the past, and three months or more have passed since the most recent vaccination.
- •Subjects who agree not to donate blood during the clinical study period.
- •If the female subject or the male subject's partner is possibility pregnancy, who can consent to use medically effective contraception during the clinical study.
排除标准
- •Subjects who have SARS-CoV-2 PCR test positive for SARS-CoV-
- •Subjects who have been infected with SARS-CoV-2 in the past or suspected of being infected.
- •Subjects with symptoms suspected of being infected with SARS-CoV-
- •Subjects suffering from severe acute diseases.
- •Current history of cardiovascular, including thrombosis, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disease, and the investigator decides the subject has a safety issue.
- •Subjects with a history of convulsions due to vaccination or epilepsy.
- •Subjects with current or past history of myocarditis or pericarditis.
- •Subjects who have thrombocytopenia, coagulopathy, and those undergoing anticoagulant therapy.
- •Subjects who have a fever of 37.5 degrees Celsius or higher on the day of administration of the investigational product.
- •Subjects who have received immunosuppressive treatment within 6 months before vaccination with this investigational product.
- •Subjects who have received other investigational products within 3 months before vaccination with this investigational product.
- •Female subjects who are pregnant, wish to become pregnant during the clinical study, or have indicated that they are breast-feeding, or have a positive pregnancy test at the time of screening.
- •Subjects who have drug allergies, including allergies to vaccines, or other allergies that are considered inappropriate for study participation in the opinion of the investigators.
- •Subjects who are positive for HIV, HBV, HCV antibody or syphilis test.
- •Subjects who have olfactory abnormalities as a result of the olfactory test performed before vaccination with the study drug and an examination by an otolaryngologist.
结局指标
主要结局
-
Safety; adverse events, specific adverse events, laboratory tests, vital signs, 12-lead ECG
次要结局
未报告次要终点
研究者
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