A first-in-human phase 1 study of ACE910, a novel factor VIII–mimetic bispecific antibody, in healthy subjects-Reference-Cited by-同舟云学术

A first-in-human phase 1 study of ACE910, a novel factor VIII–mimetic bispecific antibody, in healthy subjects

Published:2016-03-31 Issue:13 Volume:127 Page:1633-1641
ISSN:0006-4971
Container-title:Blood
language:en
Short-container-title:

Author:

Uchida Naoki¹²,Sambe Takehiko¹²,Yoneyama Koichiro³,Fukazawa Naoki³,Kawanishi Takehiko³,Kobayashi Shinichi¹,Shima Midori⁴

Affiliation:

1. Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Tokyo, Japan;

2. Department of Pharmacology, School of Medicine, Showa University, Tokyo, Japan;

3. Translational Clinical Research Division, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan; and

4. Department of Pediatrics, Nara Medical University, Nara, Japan

Abstract

Key Points Single subcutaneous dosing of ACE910 has a linear PK profile, a half-life of 4 to 5 weeks, and FVIII-mimetic procoagulant activity in humans. ACE910 at doses up to 1 mg/kg is well tolerated and has no notable adverse hypercoagulable effect in healthy Japanese and white adults.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

Link

http://ashpublications.org/blood/article-pdf/127/13/1633/1392227/1633.pdf

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