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Article(id=1291704940691476933, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1739462400000, receivedDateStr=2025-02-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896056577, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896056577, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896056577, creator=13701087609, updateTime=1785896056577, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2781, endPage=2787, ext={EN=ArticleExt(id=1291704941123490246, articleId=1291704940691476933, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Study on safety, tolerability, pharmacokinetics and immunogenicity of single and multiple doses of rIFN β-1b in healthy Chinese volunteers, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective

This current study was conducted in healthy Chinese volunteers to evaluate its safety, tolerability pharmacokinetics and immunogenicity profiles of recombinant human interferon beta-1b (rIFN β-1b) by subcutaneous administration (SC).

Methods

The clinical study included four single-dose (SD) cohorts and one multiple-dose (MD) cohort. The single-dose part was designed as a double-blind, randomized, placebo-controlled, dose-escalation (4-16 MIU dose range) study. Eight participants enrolled in each single-dose cohort were allocated (3∶1) to receive either rIFN β-1b or placebo. The multiple-dose cohort was mainly designed to assess the pharmacokinetics and immunogenicity profile of rIFN β-1b, with 8 MIU dose for eight consecutive days in eight healthy volunteers. The blood concentration of rIFN β-1b and the titre of anti-drug antibody (ADA) were quantified by a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetic parameters were calculated using a non-atrioventricular model with the WinNonlin software. The safety monitoring was carried out across the trial.

Results

All 40 healthy participants enrolled and completed the trial. In 4, 8, 12 MIU SD groups, the Cmax were (63.18±34.64)、(125.17±59.19) and (214.00±89.02) pg·mL-1, respectively; AUC0-t were (3 247.63±1 842.60)、(7 903.33±3 427.03) and (9 740.00±2 333.47) h·pg·mL-1, respectively; AUC0-∞ were (4 374.00±1 087.74)、(8 861.67±3 677.13) and (10 528.33±2 344.60) h·pg·mL-1, respectively. The mean Cmax of rIFN β-1b approximately increased linearly with dose-relationship in the SD group (4-12 MIU) and the mean AUC0-t and AUC0-∞ showed the similar treand. The median tmax ranged from 5 to 12 hours in the SD groups. The median tmax was 4 hours in the MD group and no increase of the titre level of anti-drug antibody was found. The elimination half-life (t1/2) was similar in all dose groups, approximately 50 hours. No serious adverse events occurred and all adverse events returned to normal or baseline level. The common adverse events were mainly influenza-like illness, injection site adverse reactions and fever, all of which were graded as mild (Grade 1) or moderate (Grade 2).

Conclusion

The rIFN β-1b showed safe and well-tolerated in single and multiple doses cohorts of this study. Systemic exposure of IFN β-1b increased with dose-relationship in the single-dose group. These findings support the necessity for further clinical studies.

, authors=Shao-jie GUO1, Feng WU1, Si-yang NI1, Yu-yang DAI1, Yun-kai YANG2, Wei WANG3, Xiu-li ZHAO1, authorsList=Shao-jie GUO, Feng WU, Si-yang NI, Yu-yang DAI, Yun-kai YANG, Wei WANG, Xiu-li ZHAO, authorCompany=null, correspAuthors=Xiu-li ZHAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291704941849104839, articleId=1291704940691476933, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=注射用重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的

考察单次和多次皮下注射重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性。

方法

本研究分为单剂量和多剂量两部分。单剂量部分为单次皮下给药、随机、双盲、安慰剂对照研究，剂量组从低到高依次为4、8、12和16百万国际单位（MIU），每个剂量组入组8例受试者，按3：1的比例分别接受试验药或安慰剂，主要考察药代动力学特征和耐受性；多剂量部分主要考察连续8天皮下注射8 MIU的重组人干扰素β-1b的药代动力学及免疫原性特征，共计入组8例受试者。用经验证的酶联免疫法（ELISA）检测重组人干扰素β1b的血药浓度及抗药抗体滴度。用WinNonlin软件计算药代动力学参数算。整个试验期间对志愿者的临床及实验室的观察指标进行相关的安全性评价。

结果

入组的40例健康志愿者均完成试验。在单剂量组（4~12 MIU）中，4、8和12 MIU组重组人干扰素β-1b的峰浓度（Cmax）分别为（63.18±34.64）、（125.17±59.19）和（214.00±89.02）pg·mL-1、药时曲线下面积（AUC0-t）分别为（3 247.63±1 842.60）、（7 903.33±3 427.03）和（9 740.00±2 333.47）h·pg·mL-1，AUC0-∞分别为（4 374.00±1 087.74）、（8 861.67±3 677.13）和（10 528.33±2 344.60）h·pg·mL-1，上述指标随着剂量的增加近似线性增加，中位达峰时间（tmax）范围为5~12 h；多剂量组中，中位tmax为4 h；在所有剂量组中消除半衰期（t1/2）相似，约为50 h左右。多剂量组中未见抗药抗体滴度增加。试验期间未发生严重不良事件，所有不良事件均已随访至恢复正常或达到基线水平。常见的不良反应主要为流感样反应、注射部位不良反应和发热，程度均为1~2级。

结论

注射用重组人干扰素β-1b在中国健康受试者中单次给予4~16MIU，多次给予8MIU的安全性良好、可耐受，明确了系统暴露量随剂量增加而增加的剂量范围。多次给药有无蓄积。

, authors=郭韶洁1, 武峰1, 倪四阳1, 戴玉洋1, 杨云凯2, 王伟3, 赵秀丽1, authorsList=郭韶洁, 武峰, 倪四阳, 戴玉洋, 杨云凯, 王伟, 赵秀丽, authorCompany=null, correspAuthors=赵秀丽, authorNote=

郭韶洁（1980-），女，硕士，主管药师，主要从事临床药理学研究

, correspAuthorsNote=
赵秀丽，教授，主任药师，博士生导师 Tel: （010）58268486 E-mail:
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注射用重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性研究
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郭韶洁 1 , 武峰 1 , 倪四阳 1 , 戴玉洋 1 , 杨云凯 2 , 王伟 3 , 赵秀丽 1
中国临床药理学杂志 | 药代动力学与生物等效性研究 2025,41(19): 2781-2787
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中国临床药理学杂志 |药代动力学与生物等效性研究 2025 , 41 (19) : 2781 -2787
注射用重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性研究
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郭韶洁1, 武峰1, 倪四阳1, 戴玉洋1, 杨云凯2, 王伟3, 赵秀丽1
作者信息
  • 1.首都医科大学 附属北京同仁医院 Ⅰ期研究型病房，北京 100730
  • 2.中国生物技术股份有限公司，北京 100730
  • 3.北京生物制品研究所有限责任公司，北京 100730
通讯作者:
赵秀丽，教授，主任药师，博士生导师 Tel: （010）58268486 E-mail:
作者简介:

郭韶洁（1980-），女，硕士，主管药师，主要从事临床药理学研究

Study on safety, tolerability, pharmacokinetics and immunogenicity of single and multiple doses of rIFN β-1b in healthy Chinese volunteers
Shao-jie GUO1, Feng WU1, Si-yang NI1, Yu-yang DAI1, Yun-kai YANG2, Wei WANG3, Xiu-li ZHAO1
Affiliations
  • 1.Department of Phase I Research Ward, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
  • 2.China National Biotechnology Group Corporation Limited (formerly Beijing Institute of Biological Products Co., Ltd.), Beijing 100730
  • 3.Beijing Institute of Biological Products Co., Ltd., Beijing 100730
出版时间: 2025-10-17 doi: 10.13699/j.cnki.1001-6821.2025.19.014
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摘要
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目的

考察单次和多次皮下注射重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性。

方法

本研究分为单剂量和多剂量两部分。单剂量部分为单次皮下给药、随机、双盲、安慰剂对照研究，剂量组从低到高依次为4、8、12和16百万国际单位（MIU），每个剂量组入组8例受试者，按3：1的比例分别接受试验药或安慰剂，主要考察药代动力学特征和耐受性；多剂量部分主要考察连续8天皮下注射8 MIU的重组人干扰素β-1b的药代动力学及免疫原性特征，共计入组8例受试者。用经验证的酶联免疫法（ELISA）检测重组人干扰素β1b的血药浓度及抗药抗体滴度。用WinNonlin软件计算药代动力学参数算。整个试验期间对志愿者的临床及实验室的观察指标进行相关的安全性评价。

结果

入组的40例健康志愿者均完成试验。在单剂量组（4~12 MIU）中，4、8和12 MIU组重组人干扰素β-1b的峰浓度（Cmax）分别为（63.18±34.64）、（125.17±59.19）和（214.00±89.02）pg·mL-1、药时曲线下面积（AUC0-t）分别为（3 247.63±1 842.60）、（7 903.33±3 427.03）和（9 740.00±2 333.47）h·pg·mL-1，AUC0-∞分别为（4 374.00±1 087.74）、（8 861.67±3 677.13）和（10 528.33±2 344.60）h·pg·mL-1，上述指标随着剂量的增加近似线性增加，中位达峰时间（tmax）范围为5~12 h；多剂量组中，中位tmax为4 h；在所有剂量组中消除半衰期（t1/2）相似，约为50 h左右。多剂量组中未见抗药抗体滴度增加。试验期间未发生严重不良事件，所有不良事件均已随访至恢复正常或达到基线水平。常见的不良反应主要为流感样反应、注射部位不良反应和发热，程度均为1~2级。

结论

注射用重组人干扰素β-1b在中国健康受试者中单次给予4~16MIU，多次给予8MIU的安全性良好、可耐受，明确了系统暴露量随剂量增加而增加的剂量范围。多次给药有无蓄积。

重组人干扰素β-1b  /  药代动力学  /  安全性  /  免疫原性
Objective

This current study was conducted in healthy Chinese volunteers to evaluate its safety, tolerability pharmacokinetics and immunogenicity profiles of recombinant human interferon beta-1b (rIFN β-1b) by subcutaneous administration (SC).

Methods

The clinical study included four single-dose (SD) cohorts and one multiple-dose (MD) cohort. The single-dose part was designed as a double-blind, randomized, placebo-controlled, dose-escalation (4-16 MIU dose range) study. Eight participants enrolled in each single-dose cohort were allocated (3∶1) to receive either rIFN β-1b or placebo. The multiple-dose cohort was mainly designed to assess the pharmacokinetics and immunogenicity profile of rIFN β-1b, with 8 MIU dose for eight consecutive days in eight healthy volunteers. The blood concentration of rIFN β-1b and the titre of anti-drug antibody (ADA) were quantified by a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetic parameters were calculated using a non-atrioventricular model with the WinNonlin software. The safety monitoring was carried out across the trial.

Results

All 40 healthy participants enrolled and completed the trial. In 4, 8, 12 MIU SD groups, the Cmax were (63.18±34.64)、(125.17±59.19) and (214.00±89.02) pg·mL-1, respectively; AUC0-t were (3 247.63±1 842.60)、(7 903.33±3 427.03) and (9 740.00±2 333.47) h·pg·mL-1, respectively; AUC0-∞ were (4 374.00±1 087.74)、(8 861.67±3 677.13) and (10 528.33±2 344.60) h·pg·mL-1, respectively. The mean Cmax of rIFN β-1b approximately increased linearly with dose-relationship in the SD group (4-12 MIU) and the mean AUC0-t and AUC0-∞ showed the similar treand. The median tmax ranged from 5 to 12 hours in the SD groups. The median tmax was 4 hours in the MD group and no increase of the titre level of anti-drug antibody was found. The elimination half-life (t1/2) was similar in all dose groups, approximately 50 hours. No serious adverse events occurred and all adverse events returned to normal or baseline level. The common adverse events were mainly influenza-like illness, injection site adverse reactions and fever, all of which were graded as mild (Grade 1) or moderate (Grade 2).

Conclusion

The rIFN β-1b showed safe and well-tolerated in single and multiple doses cohorts of this study. Systemic exposure of IFN β-1b increased with dose-relationship in the single-dose group. These findings support the necessity for further clinical studies.

recombinant human interferon beta-1b  /  safety  /  tolerability  /  pharmacokinetics  /  immunogenicity
郭韶洁, 武峰, 倪四阳, 戴玉洋, 杨云凯, 王伟, 赵秀丽. 注射用重组人干扰素β-1b在中国健康志愿者的安全性、耐受性、药代动力学和免疫原性研究. 中国临床药理学杂志, 2025 , 41 (19) : 2781 -2787 . DOI: 10.13699/j.cnki.1001-6821.2025.19.014
Shao-jie GUO, Feng WU, Si-yang NI, Yu-yang DAI, Yun-kai YANG, Wei WANG, Xiu-li ZHAO. Study on safety, tolerability, pharmacokinetics and immunogenicity of single and multiple doses of rIFN β-1b in healthy Chinese volunteers[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (19) : 2781 -2787 . DOI: 10.13699/j.cnki.1001-6821.2025.19.014
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2025年第41卷第19期
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doi: 10.13699/j.cnki.1001-6821.2025.19.014
  • 接收时间：2025-02-14
  • 首发时间：2026-08-05
  • 出版时间：2025-10-17
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  • 收稿日期：2025-02-14
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北京市科委(Z191100007619038)
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    1.首都医科大学 附属北京同仁医院 Ⅰ期研究型病房，北京 100730
    2.中国生物技术股份有限公司，北京 100730
    3.北京生物制品研究所有限责任公司，北京 100730

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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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