A phase I clinical study: evaluation of safety, tolerability, and population pharmacokinetic-pharmacodynamic target attainment analysis of etimicin sulfate among healthy Chinese participants

耐受性 药代动力学 药效学 医学 药理学 中国人口 人口 不利影响 环境卫生 化学 生物化学 基因型 基因
作者
Xue Zhao,Jianwei Ren,Xin Xiao Zheng,Sheng Wang,Zhen Wu,Hongzhong Liu,Weidong Tian,Dandan Zhao,Yingchun Xu,Xiaohong Han
出处
期刊:International Journal of Antimicrobial Agents [Elsevier BV]
卷期号:64 (4): 107287-107287
标识
DOI:10.1016/j.ijantimicag.2024.107287
摘要

This phase I clinical study aimed to assess the safety, tolerability, and population pharmacokinetic-pharmacodynamics (PK-PD) target attainment analysis of etimicin sulfate in healthy participants, and to provide scientific reference for further development of clinical breakpoints. A total of 24 healthy Chinese subjects were enrolled in this study and received an etimicin sulfate infusion. A population PK model was constructed for the estimation of the PK profiles of etimicin sulfate. The area under the concentration-time curve divided by the minimum inhibitory concentration (AUC0-24h/MIC) and the peak concentration divided by the MIC (Cmax/MIC) were selected as the PK/PD indices. The probability of target attainment (PTA) was calculated for each designed dosing regimen using Monte Carlo simulations. The minimum MIC value with a PTA ≥ 90% for each regimen was considered as the PK/PD cutoff values. Etimicin sulfate demonstrated safety, tolerability, and predictable PK characteristics. No deaths or serious adverse events were reported. Seven treatment-emergent adverse events (TEAEs) were reported by five participants; all TEAEs were minor and were rapidly relieved. A two-compartment model was developed and validated for describing the PK features of etimicin sulfate among Chinese healthy participants. The diagnostic goodness-of-fit plots and visual predictive check plots showed that this developed model could describe these data well. The PTA results showed that etimicin sulfate provided clinical improvement against strains with an MIC of 0.5-1 mg/L and below, and antibacterial effect against strains with an MIC of 0.25 mg/L and below. However, etimicin sulfate had limited clinical efficacy for clinical isolates with MIC values > 1 mg/L.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
杨召完成签到,获得积分10
刚刚
大橙子发布了新的文献求助10
4秒前
酷波er应助陈昊采纳,获得10
8秒前
hcsdgf完成签到 ,获得积分10
10秒前
可取完成签到,获得积分10
11秒前
zss完成签到 ,获得积分10
11秒前
12秒前
heart完成签到 ,获得积分10
14秒前
15秒前
lingyu完成签到,获得积分10
16秒前
ym完成签到 ,获得积分10
17秒前
Masetti1完成签到 ,获得积分10
19秒前
jenny发布了新的文献求助10
20秒前
忧虑的静柏完成签到 ,获得积分10
21秒前
21秒前
强公子发布了新的文献求助10
25秒前
自由的远侵完成签到 ,获得积分10
33秒前
巧克力手印完成签到,获得积分10
34秒前
屈岂愈发布了新的文献求助10
34秒前
35秒前
大橙子发布了新的文献求助10
36秒前
量子星尘发布了新的文献求助10
37秒前
jenny完成签到,获得积分10
38秒前
祁乐安完成签到,获得积分10
39秒前
naiyouqiu1989完成签到,获得积分10
40秒前
zjhzslq发布了新的文献求助10
41秒前
baoxiaozhai完成签到 ,获得积分10
42秒前
fy完成签到,获得积分10
43秒前
强公子完成签到,获得积分10
44秒前
50秒前
song完成签到 ,获得积分10
51秒前
怡然小蚂蚁完成签到 ,获得积分10
51秒前
小橙子完成签到,获得积分10
53秒前
SciGPT应助滴答采纳,获得10
53秒前
大气白翠完成签到,获得积分10
54秒前
确幸完成签到,获得积分10
54秒前
zjhzslq完成签到,获得积分10
54秒前
xdc发布了新的文献求助10
55秒前
ommphey完成签到 ,获得积分10
55秒前
牛哥还是强啊完成签到 ,获得积分10
56秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038128
求助须知:如何正确求助?哪些是违规求助? 3575831
关于积分的说明 11373827
捐赠科研通 3305610
什么是DOI,文献DOI怎么找? 1819255
邀请新用户注册赠送积分活动 892655
科研通“疑难数据库(出版商)”最低求助积分说明 815022