[Translation] An interventional, randomized, open-label, parallel-group, single-dose trial to investigate the safety, immunogenicity, tolerability, and pharmacokinetic characteristics of Lu AF82422 in healthy Chinese and healthy Caucasian participants

本试验的主要目标是了解以下几个方面：a) Lu AF82422的安全性和耐受性（参与者在治疗过程中是否出现任何新的或加重的医疗问题），b) Lu AF82422的免疫原性（药物引发不良免疫反应的可能性），c) Lu AF82422的药代动力学参数（药物在体内的吸收、分布和代谢过程）。在试验期间，健康的成年参与者（中国和高加索人）将接受一次Lu AF82422的静脉输注。

[Translation]

The main objectives of this trial are to understand the following aspects: a) the safety and tolerability of Lu AF82422 (whether participants develop any new or worsening medical problems during treatment), b) the immunogenicity of Lu AF82422 (the possibility of the drug triggering an adverse immune response), and c) the pharmacokinetic parameters of Lu AF82422 (the absorption, distribution, and metabolism of the drug in the body). During the trial, healthy adult participants (Chinese and Caucasian) will receive a single intravenous infusion of Lu AF82422.

Start Date18 Mar 2024

Sponsor / Collaborator

Patheon Manufacturing Services LLC

[+2]

CTR20211849 / RecruitingPhase 3

一项评价 eptinezumab 对于偏头痛预防性治疗的有效性和安全性的干预性、随机化、双盲、平行分组、安慰剂对照研究

[Translation] An interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of migraine

主要目的评价eptinezumab预防慢性偏头痛的有效性次要目的评价eptinezumab对健康相关生活质量、医疗资源使用（HCRU）和工作效率的有效性探索性目的评估eptinezumab的暴露量安全性目的评价eptinezumab的安全性和耐受性

[Translation]

Primary objective To evaluate the effectiveness of eptinezumab in preventing chronic migraine Secondary objectives To evaluate the effectiveness of eptinezumab on health-related quality of life, healthcare resource use (HCRU), and work productivity Exploratory objectives To assess the exposure of eptinezumab Safety objectives To evaluate the safety and tolerability of eptinezumab

Start Date07 Sep 2021

Sponsor / Collaborator

H. Lundbeck A/S

[+2]

CTR20210462 / CompletedPhase 1

在健康中国受试者中评价Eptinezumab的安全性、耐受性和药代动力学特征的干预性、随机、开放、平行单次给药临床研究

[Translation] An interventional, randomized, open-label, parallel single-dose clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of Eptinezumab in healthy Chinese subjects

主要目的：在中国健康受试者中研究Eptinezumab单次静脉输注的药代动力学（PK）参数安全性目的：在中国健康受试者中评价Eptinezumab单次静脉输注的安全性和耐受性免疫原性目的：在中国健康受试者中评价Eptinezumab单次静脉输注的免疫原性

[Translation]

Primary objective: To study the pharmacokinetic (PK) parameters of a single intravenous infusion of Eptinezumab in healthy Chinese subjects Safety objective: To evaluate the safety and tolerability of a single intravenous infusion of Eptinezumab in healthy Chinese subjects Immunogenicity objective: To evaluate the immunogenicity of a single intravenous infusion of Eptinezumab in healthy Chinese subjects

Start Date20 Apr 2021

Sponsor / Collaborator

H. Lundbeck A/S

[+2]

100 Clinical Results associated with Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.

0 Patents (Medical) associated with Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.

Literatures (Medical) associated with Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.

01 Nov 2023·Clinical Drug Investigation

Pharmacokinetics and Safety of Eptinezumab in Healthy Chinese Participants: A Randomized Clinical Trial

Article

Author: Cui, Ellen ; Ettrup, Anders ; Østergaard, Jette Buch ; Li, Xue-Ning ; Larsen, Frank ; Ryding, Janka ; Xu, Hong-Rong ; Petersen, Kamilla Buchberg

BACKGROUND AND OBJECTIVEMost evidence suggests that the pharmacokinetics of monoclonal antibodies (mAbs) are not meaningfully altered by patient characteristics, including racial/ethnic differences. Nevertheless, the pharmacokinetic profile of eptinezumab has not been evaluated in a Chinese population. This study was designed to confirm the hypothesis that the pharmacokinetic profile of the anti-calcitonin gene-related peptide mAb, eptinezumab, is similar in healthy Chinese individuals to that of healthy non-Asian individuals and non-Asian patients with migraine.METHODSOver a study period of 12 weeks, healthy adult Chinese participants (N = 20) were randomized (1:1) to receive a single intravenous dose of eptinezumab 100 mg (n = 10) or 300 mg (n = 10) in a prospective, single-site, open-label parallel-group trial. Blood samples for the evaluation of plasma eptinezumab concentrations were obtained over 84 days, and standard pharmacokinetic parameters were derived.RESULTSMean maximum plasma concentrations (C_max) of eptinezumab occurred 1.0-1.5 h post start of infusion, were similar between the 100 mg and 300 mg dose groups, and slowly declined in a biphasic manner. C_max and area under the drug concentration-time curve (AUC) increased in a dose-proportional manner. Volume of distribution and clearance were similar between the 100 mg and 300 mg dose groups, and half-life was 22.5-28.1 days. Eptinezumab was generally well tolerated with no new safety signals identified. Only one participant, randomized to the 100 mg dose group, was positive for eptinezumab anti-drug antibodies, but negative for neutralizing antibodies, with no impact on pharmacokinetics.CONCLUSIONThe pharmacokinetic profile of eptinezumab in healthy Chinese individuals was generally similar to that reported for non-Asian populations with migraine, and eptinezumab was generally well tolerated. Evaluation of immunogenicity showed no evidence of an impact of anti-drug antibodies or neutralizing antibodies on safety profiles. This supports the globally approved doses of 100 mg and 300 mg as being appropriate for Chinese patients with episodic migraine or chronic migraine.

01 Jul 2023·Drug safety

Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson's Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study.

Article

Author: Song, Zhuolun ; Hu, Xingyue ; Wu, Yuncheng ; Shao, Ming ; Mao, Wei ; Cao, Shuai ; Su, Wen ; Tang, Beisha ; Liang, Zhanhua ; Chen, Haibo ; Zhang, Kezhong ; Liu, Zhenguo ; Wei, Wenshi

INTRODUCTIONRasagiline is indicated for treating idiopathic Parkinson's disease (PD) as monotherapy and adjunct therapy to levodopa in patients.OBJECTIVESTo assess the post-marketing safety and tolerability of rasagiline in Chinese PD patients, as well as its effectiveness in improving motor symptoms.METHODSThis prospective, non-interventional, multicenter, cohort study included PD patients administered rasagiline monotherapy or adjunct therapy to levodopa. The primary outcome was the incidence of adverse drug reactions (ADRs) according to MedDRA^® (version 22.0), and the secondary outcomes were the Parkinson's Disease Unified Rating Scale (UPDRS) part III, Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Global-Improvement (CGI-I), assessed at Weeks 4, 12, and 24.RESULTSIn total, 734 patients, 95 in the monotherapy subgroup and 639 in the adjunct therapy subgroup, were included in the safety population. The incidence rates of all ADRs were comparable between the monotherapy (15.8%) and adjunct therapy (13.6%) subgroups. The most common ADRs by system organ class were nervous system disorders (5.6%), gastrointestinal disorders (3.3%), psychiatric disorders (1.8%), vascular disorders (1.2%), and general disorders and administration site conditions (1.1%). Five (0.7%) participants experienced 5 serious ADRs. Improvements in UPDRS part III, CGI-S and CGI-I at Weeks 4, 12 and 24 from baseline were observed.CONCLUSIONSSafety data in this study indicated no extra safety concerns. Rasagiline is generally safe and well tolerated in Chinese PD patients. The safety profile and tolerability were in line with the established safety profile. Moreover, rasagiline reduced the severity of PD motor symptoms, confirming findings by previous clinical trials.

01 Nov 2019·Advances in TherapyQ3 · MEDICINE

Pharmacokinetics and Safety of Vortioxetine in the Chinese Population

Q3 · MEDICINE

Article

Author: Wang, Gang ; Højer, Astrid-Maria ; Miao, Jia ; Hou, Jie ; Zhao, Yan ; Areberg, Johan ; Ettrup, Anders

INTRODUCTIONMajor depressive disorder (MDD) is associated with a significant burden of disease in China. Awareness and better access to treatments could help alleviate the burden associated with MDD. Because variations have been observed in the pharmacokinetics (PK) of antidepressants across different races and ethnicities, evaluation of the clinical pharmacology of vortioxetine in diverse populations remains important to assess the potential need for dose adjustments.METHODSData were pooled from two phase I open-label PK studies in healthy Chinese subjects, and one phase III double-blind noninferiority study in Chinese patients with MDD to describe the PK and safety data for vortioxetine. Doses in these studies ranged from 10 mg (single dose) to 10 and 20 mg (multiple daily doses). A population PK analysis of vortioxetine in the Chinese population was conducted using nonlinear mixed-effect modeling.RESULTSIn total, 186 individuals were included in the PK analysis: 79 healthy Chinese subjects and 107 Chinese patients with MDD. No clinically significant differences in the PK of vortioxetine were observed between the Chinese population and the previous data in non-Chinese populations. Because of a generally lower weight in the Chinese population compared with the non-Chinese population, exposures were 19% and 18% higher in the Chinese population than in the non-Chinese population (for maximum observed plasma concentration and area under the plasma concentration-time curve, respectively), which is not considered clinically relevant. A high prevalence of pruritus was observed in one phase I PK study (56% overall); however, this was not reflected in the phase III study in Chinese patients with MDD (0.8%).CONCLUSIONSThe PK parameters of vortioxetine in Chinese subjects were comparable to previous data in non-Chinese subjects. Overall, no new safety concerns were raised among the Chinese population. On the basis of this analysis, the tolerability profile of vortioxetine in Chinese healthy subjects and in patients with MDD is expected to be comparable to that in the non-Chinese population.FUNDINGH. Lundbeck A/S, Valby, Denmark.TRIAL REGISTRATIONNCT01676571.

100 Deals associated with Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.

100 Translational Medicine associated with Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.

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