Pharmacokinetics and Safety of Erenumab after a Single Subcutaneous Injection Dose in Healthy Chinese Subjects.
Autor: | Shen Q; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Jin Y; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Di X; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Hu C; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Liu R; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Wang Y; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Qi X; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Wang Y; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China., Wang Z; Clinical Trial Center/NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, No.5 Telecom Road, Wuhou District, Chengdu, 610041, China. wangzhenlei@wchscu.cn. |
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Jazyk: | angličtina |
Zdroj: | Clinical drug investigation [Clin Drug Investig] 2022 Jul; Vol. 42 (7), pp. 623-630. Date of Electronic Publication: 2022 Jun 21. |
DOI: | 10.1007/s40261-022-01171-5 |
Abstrakt: | Background and Objective: Erenumab is the first-in-class, selective, and competitive human monoclonal antibody antagonist of the calcitonin gene-related peptide (CGRP) receptor that has been shown to be effective and well-tolerated in the preventive therapy of episodic and chronic migraine. The pharmacokinetics of erenumab may be affected by differences in race and ethnicity, which can lead to suboptimal outcomes. The present study was conducted to assess the single-dose pharmacokinetics and safety of erenumab in healthy Chinese subjects. Methods: This was an open-label, randomized, parallel group, non-confirmatory, single-dose study in healthy Chinese subjects. A total of 24 healthy Chinese subjects of both sexes aged between 14 and 45 years were administered a single subcutaneous injection of erenumab 70 mg or 140 mg. The serum concentration of erenumab was quantified using a validated enzyme-linked immunosorbent assay method and pharmacokinetic parameters were determined using non-compartmental models. Safety was also assessed. Results: A total of 55 subjects were screened for eligibility and 25 subjects were randomized to receive study treatments (12 subjects to the 70-mg erenumab group and 13 subjects to the 140-mg erenumab group). Erenumab was absorbed slowly with maximum serum concentration (C Conclusions: Erenumab was safe and well tolerated after a single subcutaneous injection in healthy Chinese subjects. The systemic exposure in Chinese subjects in terms of AUC Chinese Clinical Trial Registry No: ChiCTR2000032435. (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.) |
Databáze: | MEDLINE |
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