Efbemalenograstim Alfa (F-627)是一种新型长效rhG-CSF,在中国健康受试者中的药代动力学、药效学、安全性和耐受性:一项开放标签、单中心I期研究

IF 2.7 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Zhihai Cao, Yao Li, Denny Hou, Shufang Wang, Wei Yao, Gaochong Zhang, Jianmin Chen, Zhengwei Tang, Linda Song, Xingna Zhao, Xiaoxiang Chu, Xiaoyan Wang, Renshu Li, Wei Hu
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引用次数: 0

摘要

背景与目的:在临床实践中,粒细胞集落刺激因子(G-CSF)常用于降低感染风险,避免化疗剂量减少或延迟导致的不良后果。Efbemalenograstim alfa(也称为F-627)是与pegfilgrastim相比,非聚乙二醇化但长效(每周期一次)重组人粒细胞集落刺激因子(rhG-CSF)。本研究旨在获得F-627在中国健康受试者体内的药代动力学(PK)/药效学(PD)、安全性和耐受性数据。方法:这是一项单中心、开放标签的I期临床研究,涉及24名健康的中国志愿者(性别比例为1:1)。所有的参与者都被一次性皮下注射20毫克F-627到腹部。结果:在本研究中,15名(62.5%)参与者报告了28例治疗相关不良事件。PK/PD数据显示,在健康的中国参与者中,单次皮下注射20 mg F-627腹腔注射后,血清浓度在给药后36小时达到峰值,而绝对中性粒细胞计数(ANC)在96小时达到峰值。达到峰值后,F-627血清水平在120小时内迅速下降到低浓度,而ANC在第15天逐渐下降到接近基线水平。在不同性别之间,血清浓度和ANC动力学也有类似的变化趋势。结论:这项I期研究表明,在中国健康人群中,20mg F-627具有良好的耐受性和良好的安全性。PK和PD数据相关良好,跨性别一致。试验注册:该试验于2024年9月10日在中国临床试验注册中心(chictr.org.cn)注册(注册ID: ChiCTR2400089548)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Efbemalenograstim Alfa (F-627), a Novel Long-Acting rhG-CSF, in Healthy Chinese Participants: An Open-Label, Single-Center Phase I Study.

Background and objectives: In clinical practice, granulocyte colony-stimulating factor (G-CSF) is often used to lower infection risk and avoid poor outcomes from chemotherapy dose reduction or delay. Efbemalenograstim alfa (also known as F-627) is a non-pegylated but long-acting (once-per-cycle) recombinant human granulocyte colony-stimulating factor (rhG-CSF) compared with pegfilgrastim. This study was designed to obtain pharmacokinetic (PK)/pharmacodynamic (PD), safety, and tolerability data for F-627 in healthy Chinese participants.

Methods: This was a single-center, open-label phase I clinical study involving 24 healthy Chinese volunteers (sex ratio = 1:1). All the participants were administered a single subcutaneous injection of 20 mg F-627 into the abdomen.

Results: In this study, 15 (62.5%) participants reported 28 treatment-related adverse events. PK/PD data showed that after a single 20 mg subcutaneous (SC) F-627 abdominal injection in healthy Chinese participants, serum concentrations peaked at 36 h post dose, while the absolute neutrophil count (ANC) peaked at 96 h. After peaking, F-627 serum levels decreased rapidly to low concentrations by 120 h, while ANC declined gradually to near baseline by day 15. Similar trends in serum concentration and ANC kinetics were seen between sex.

Conclusions: This phase I study showed that 20 mg F-627 was well tolerated and exhibited a favorable safety profile in a healthy Chinese population. The PK and PD data correlated well and were consistent across sex.

Trial registration: This trial was registered at the Chinese Clinical Trial Registry (chictr.org.cn) on 10 September 2024 (registration ID: ChiCTR2400089548).

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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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