The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

开始日期2020-06-01

申办/合作机构

Nobelpharma Co., Ltd.

100 项与 NPC-21 相关的临床结果

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100 项与 NPC-21 相关的转化医学

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100 项与 NPC-21 相关的专利（医药）

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项与 NPC-21 相关的文献（医药）

2022-06-01·Clinical Pharmacology in Drug Development

Pharmacokinetics, Safety, and Tolerability of NPC‐21, an Anti‐Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo‐Controlled, First‐in‐Human Phase 1 Study

Article

作者: Furihata, Kenichi ; Niwa, Takuro ; Ezoe, Sachiko ; Watanabe, Tatsuya ; Hamada, Izumi

AbstractNPC‐21 (EV2038) is a fully human monoclonal antibody that targets the antigenic domain 1 of glycoprotein B on the human cytomegalovirus (hCMV) envelope. NPC‐21 has been shown to have broadly neutralizing activity and to inhibit cell‐to‐cell transmission of hCMV in preclinical studies. It is currently in development for the prophylactic or preemptive treatment of hCMV in patients receiving a solid‐organ transplant or hematopoietic stem cell transplant. A first‐in‐human phase 1 study was conducted to assess the pharmacokinetics, safety, and tolerability of NPC‐21 in healthy adult men. Forty participants (Japanese, n = 32; White, n = 8) were randomly assigned to receive a single intravenous dose of NPC‐21 1, 3, 10, or 20 mg/kg or placebo. Six Japanese participants were included in each dose group and six White participants received a 10‐mg/kg dose. The placebo group included 8 Japanese participants and 2 White participants. All 40 participants completed the study. Serum concentration, maximum serum concentration, area under the plasma concentration–time curve from time 0 to the last measurable concentration, and area under the plasma concentration–time curve from time 0 to infinity increased dose dependently; dose proportionality was linear. NPC‐21 demonstrated a biphasic elimination pattern, with an estimated half‐life between 612 and 790 hours. NPC‐21 was safe and well tolerated up to 20 mg/kg. All adverse events were mild, and none led to treatment discontinuation or were considered related to the study drug. There were no differences in pharmacokinetics or safety between Japanese and White participants. These results support further investigation of NPC‐21.

100 项与 NPC-21 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
巨细胞病毒感染	临床2期	美国	Nobelpharma Co., Ltd.	2020-06-01
巨细胞病毒感染	临床2期	日本	Nobelpharma Co., Ltd.	2020-06-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04225923 (CTgov)	临床2期	巨细胞病毒感染	87	NPC-21 Low dose (NPC-21 Low Dose)	願鬱遞鑰觸遞鹹廠艱膚(衊觸壓繭遞餘製餘膚艱) = 齋獵鹽簾獵願遞蓋鹹鹹窪齋餘蓋觸積鏇遞廠餘 (顧糧範鬱鏇觸壓範蓋簾, 壓簾艱蓋淵窪淵憲遞獵 ~ 獵鏇淵簾糧鏇壓繭廠廠) 更多	-	2024-06-28
				NPC-21 High dose (NPC-21 High Dose)	願鬱遞鑰觸遞鹹廠艱膚(衊觸壓繭遞餘製餘膚艱) = 壓醖壓選夢獵觸鏇艱築窪齋餘蓋觸積鏇遞廠餘 (顧糧範鬱鏇觸壓範蓋簾, 蓋選夢蓋廠簾齋積壓鬱 ~ 醖築觸蓋繭選構壓繭顧) 更多