Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine.-临床诊疗知识库

Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine.

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作者：

Jan, de Hoon；Anne, Van Hecken；Corinne, Vandermeulen；Lucy, Yan；Brian, Smith；Jiyun Sunny, Chen；Edgar, Bautista；Lisa, Hamilton；Javier, Waksman；Thuy, Vu；Gabriel, Vargas

来源：

Clinical pharmacology and therapeutics 2017 年

标签：

Migraine headache calcitonin gene-related peptide pharmacokinetics

Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) signaling are being explored as prophylactic treatments for migraine. Erenumab (AMG 334) is the first potent, selective, and competitive human mAb antagonist of the CGRP receptor. We report the data from two phase 1 studies assessing the safety, pharmacokinetics (PK), and pharmacodynamics of single and multiple administrations of erenumab in healthy subjects and patients with migraine. The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin (Ig)G2 antibodies. Single doses of erenumab resulted in >75

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