JPRN-jRCT2031230116进行中（未招募）1 期
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
Tsubaki Atsushi0 个研究点目标入组 84 人开始时间: 2023年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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-2.
- •-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-2.
- •-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.
研究者
相似试验
进行中（未招募）
不适用
A clinical study to investigate the pharmacokinetics safety, and tolerability of a single dose of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy (GSK Study Number DMD114118)Duchenne Muscular DystrophyEUCTR2010-024566-22-Outside-EU/EEAGlaxoSmithKline Research and Development LTD32
进行中（未招募）
1 期
A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/ADuchenne Muscular DystrophyEUCTR2010-024566-22-FRGlaxoSmithKline Research and Development LTD32
招募中
不适用
Multi-center Phase 2 Trial for Orally Administered M002 to Evaluate Evaluate Safety and Efficacy in Patients with Knee and Hip OsteoarthritisDiseases of the musculoskeletal system and connective tissueKCT0008130Mecoxcuremed180
已完成
不适用
An interventional, randomized, double-blind, placebo-controlled, parallel-assignment, safety/efficacy study for treatment of chronic middle ear infection in adult patients with the antimicrobial peptide OP-145ISRCTN84220089OctoPlus N.V. (The Netherlands)
已完成
1 期
An ascending single dose, randomised, double-blind, placebo-controlled phase 1 study of the tolerability, pharmacokinetics and pharmacodynamics of AJM300 in healthy adult males in the fasting and fed statesHealthy adult SubjectsJPRN-jRCT1080224924EA Pharma Co., Ltd62