JPRN-jRCT2051200092进行中（未招募）1 期
A Phase 1/2, randomized, double-blind, placebo-controlled, parallel-group study of S-268019 in Japanese adult participants
agata Tsutae0 个研究点目标入组 300 人开始时间: 2020年12月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Phase 1 Part-A:
- •-A person with Japanese nationality.
- •-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
- •-Apparently healthy as determined by medical assessment.
- •-Body mass index (BMI) within the range 18.5 to 25.0 (inclusive) at Screening.
- •Phase 1 Part-B:
- •-A person with Japanese nationality.
- •-Participant must be 65 years of age or above, at the time of signing the ICF.
- •-BMI within the range 18.5 to 30.0 (inclusive) at Screening.
- •Phase 1 Part-C:
- •-A person with Japanese nationality.
- •-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
- •-Apparently healthy as determined by medical assessment.
- •-BMI within the range 18.5 to 30.0 (inclusive) at Screening.
- •Phase 2 Part:
- •-A person with Japanese nationality.
- •-Participant must be 20 to 64 years of age inclusive, at the time of signing the ICF.
- •-BMI within the range 18.5 to 30.0 (inclusive) at Screening. et, al.
排除标准
- •Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part:
- •-Positive SARS-CoV-2 antigen test result at Screening.
- •-Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy
- •-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.
- •-Past use of vaccines related to SARS-CoV-2 prior to the first vaccination.
- •-Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).
- •Phase 1 Part-A and Phase 1 Part-C:
- •-Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccination.
- •-Past use of immunosuppressive drug within 6 months prior to the first vaccination.
- •The following applies to Phase 1 Part-B and Phase 2 Part:
- •-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.
研究者
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