Article(id=1292130388445519990, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.06.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1770739200000, receivedDateStr=2026-02-11, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997491226, onlineDateStr=2026-08-06, pubDate=1774627200000, pubDateStr=2026-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997491226, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997491226, creator=13701087609, updateTime=1785997491226, updator=13701087609, issue=Issue{id=1292130360968630762, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1774627200000', pubDateStr='2026-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997484675, creator='13701087609', updateTime=1786014452071, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201527440068743, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201527440068744, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=791, endPage=798, ext={EN=ArticleExt(id=1292130388638457975, articleId=1292130388445519990, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Toxicological study of repeated-dose administration of the investigational drug HYH2002 injection in rats, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the effects of repeated-dose toxicity of the candidate drug HYH2002 injection in Sprague-Dawley (SD) rats, thereby providing a basis for its use in clinical trials.
Methods A total of 120 SD rats (half male, half female) were randomly divided into four groups. Group 1 (vehicle control) received the blank formulation solution. Groups 2, 3, and 4 were administered HYH2002 injection at doses of 0.60, 3.00, and 9.00 mg·kg-1, respectively. The test article was administered once daily via tail vein infusion for 2 weeks, followed by a 2-week recovery period. Parameters including clinical observations, body weight, food consumption, body temperature, ophthalmological examinations, hematology, coagulation parameters, clinical biochemistry, and urinalysis were assessed at scheduled intervals. Necropsy, gross observations, and histopathological examinations were conducted at the end of the dosing period and the recovery period.
Results Animals in the 9.00 mg·kg-1 group exhibited decreases in body weight and food consumption. Hematological changes included decreases in red blood cell (RBC) count, hemoglobin (HGB), hematocrit (HCT), and lymphocyte count (Lymph), alongside increases in neutrophil count (Neut), mean corpuscular volume (MCV), and reticulocyte count (Retic). Clinical biochemistry showed a decrease in albumin (Alb). These changes were reversible after the 2-week recovery period. No test article-related adverse effects were observed in the 0.60 and 3.00 mg·kg-1 groups. Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) was determined to be 3.00 mg·kg-1, which is 50 times the effective dose (0.06 mg·kg-1) in a rat model of gastric ulcer.
Conclusion HYH2002 injection demonstrates a favorable safety profile within the anticipated therapeutic dose range, suggesting a low risk for clinical trials.
, authors=Xue-qing CHENG, Wen-xi XIAO, Jun-hua LIU, Bin WANG, Li-fang XIE, authorsList=Xue-qing CHENG, Wen-xi XIAO, Jun-hua LIU, Bin WANG, Li-fang XIE, authorCompany=null, correspAuthors=Wen-xi XIAO, 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=1292130388869144696, articleId=1292130388445519990, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=候选新药HYH2002注射液大鼠重复给药的毒理学研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 探究候选新药HYH2002注射液对SD大鼠重复给药毒性的影响，为临床试验用药提供依据。
方法 将120只SD大鼠（60只/性别），随机分为对照组（给予HYH2002注射液空白溶液作为溶媒）、低剂量实验组（0.60 mg·kg-1 HYH2002）、中剂量实验组（13.00 mg·kg-1 HYH2002）、高剂量实验组（19.00 mg·kg-1 HYH2002）。动物尾静脉输注给药，每天给药1次，连续给药2周，恢复期2周。试验期间，定期对动物的临床观察、体重、食量、体温、眼科检查、血细胞计数、凝血功能、血液生化、尿液分析等指标进行检查，同时给药末期及恢复期末进行解剖、大体观察和病理学检查。
结果 9.00 mg·kg-1剂量组动物可见体重和食量降低，血细胞计数可见红细胞（RBC）、血红蛋白（HGB）、红细胞压积（HCT）和淋巴细胞计数（Lymph）降低，中性粒细胞计数（Neut）、平均红细胞体积（MCV）和网织红细胞计数（Retic）升高，血液生化可见Alb降低，上述改变停药恢复2周后均可见恢复。0.60和3.00 mg·kg-1剂量组动物未见与HYH2002相关的毒性反应。因此，在本试验条件下，未观察到临床不良反应的剂量水平（NOAEL）为3.00 mg·kg-1，相当于大鼠胃溃疡模型起效剂量（0.06 mg·kg-1）的50倍。
结论 HYH2002注射液治疗剂量范围内用药安全性高，临床试验安全性风险较低。
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程雪清（1985-），男，高级工程师，主要从事药物研发及药品注册相关工作
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