JPRN-jRCT2071200117已完成1 期
A PHASE I, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS OF CASIRIVIMAB AND IMDEVIMAB IN JAPANESE ADULT VOLUNTEERS
anki Toshihiro0 个研究点目标入组 22 人开始时间: 2021年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
It was confirmed that single IV administration of 2400 mg, 8000 mg and single SC administration of 1200 mg of the study drug for Japanese adult volunteers were generally safe and tolerable. In the single IV dose cohort and the single SC dose cohort, the mean serum casirivimab and imdevimab concentrations remained above the therapeutic target drug level of 20 mg/L up to 28 days after administration in any dose groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •Absence of findings suggestive of active disease
- •- For subjects with chronic diseases, maintaining stable state at least 6 months prior to screening
- •- Willingness and ability to comply with the requirements of the study protocol
- •- Consent to contraception
排除标准
- •- Positive diagnostic test results for SARS-CoV-2 infection using samples collected within 72 hours prior to enrollment
- •- A History of positive diagnostic tests for SARS-CoV-2 infection
- •- Medically attended acute disease, systemic administration of antibiotics, or hospitalization at least one night for any reason within 30 days prior to screening
- •- One or more clinically significant abnormal laboratory results at screening
- •- A severe allergy, anaphylactic reaction or hypersensitivity to chimeric, human, humanized antibodies or fusion protein or drug (including additives)
研究者
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