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Translational PK/PD and model-informed development of JNJ-67842125, a F reversal agent for JNJ-64179375, a long-acting thrombin inhibitor

Br J Pharmacol. 2021-05; 
Vivaswath S Ayyar, Pharavee Jaiprasart, Brian Geist, Zheng Huang Devine, Martin Case, Anasuya Hazra, Chyi-Hung Hsu, Madhu Chintala, Weirong Wang
Products/Services Used Details Operation
Polyclonal Antibody Services … system (BioRad). For the RA candidates including ICHB-256, ICHB-164 and ICHB-281, a biosensor surface was prepared by coupling an anti-His6 mAb (GenScript Cat #A00186) to the modified alginate polymer layer surface of a GLC chip (BioRad, Cat #176-5011) using … Get A Quote


objective: Antigen-binding fragment (F ) reversal agents (RAs) were developed to reverse, in situations of bleeding emergency, the anticoagulant activity of JNJ-64179375 (JNJ-9375), a monoclonal antibody that specifically binds exosite-1 on thrombin and functions as a long-acting anticoagulant. methods: The pharmacokinetic and pharmacodynamic (PK/PD) activities of three RAs with varying in vitro binding affinities to JNJ-9375 were characterized in cynomolgus monkeys. The time course of JNJ-9375 anticoagulant activity and reversal effects of each RA were evaluated. A mechanism-based PK/PD model, which integrated free serum concentrations of RA, total and free serum concentrations of JNJ-9375, and thrombin time (... More


Antibodies (therapeutic), Blood Pharmacology, Mathematical modeling, Pharmacodynamics, Pharmacokinetics, Translational Pharmacology