FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4378781424> ?p ?o ?g. }

• W4378781424 endingPage "562" @default.
• W4378781424 startingPage "553" @default.
• W4378781424 abstract "ABSTRACTBackground The study aimed to investigate the safety, pharmacokinetics (PK), and efficacy of YJ001 spray, a candidate drug for diabetic neuropathic pain (DNP) therapy.Research design & methods Forty-two healthy subjects received one of four single doses (240, 480, 720, 960 mg) of YJ001 spray or placebo, and 20 patients with DNP received repeated doses (240 and 480 mg) of YJ001 spray or placebo via topical route of administration to the local skin of both feet. Safety, and efficacy assessments were performed, and blood samples were collected for PK analyses.Results The pharmacokinetic results revealed that the concentrations of YJ001 and its metabolites were low, and most of them were lower than the lower limit of quantitation. In patients with DNP, treatment with a 480 mg YJ001 spray dose significantly reduced pain and improved sleep quality compared with placebo. No serious adverse events (SAEs) or clinically significant findings of the safety parameters were observed.Conclusion Systemic exposure to YJ001 and its metabolites is low after YJ001 spray is applied locally to the skin, which will reduce systemic toxicity and adverse reactions. YJ001 appears to be well tolerated and potentially effective in the management of DNP and is a promising new remedy for DNP.KEYWORDS: YJ001diabetic neuropathic pain (DNP)pharmacokineticsplacebotolerability AcknowledgmentsThis study was sponsored by Zhejiang Yuejia Pharmaceuticals Co., Ltd. We thank the subjects who participating in this study, as well as all the investigators and research staff. We also thank the National Medical Products Administration of China for its supervision of this study.Declaration of interestAuthors J. Zhang and Z. Hou were employed by Zhejiang Yuejia Pharmaceuticals Co., Ltd. J. Zhang has two patents issued by World Intellectual Property Organization, one is a bottle and a bottle cap device thereof for spray (US20210107023) and another one is a stable pharmaceutical composition containing a non-steroidal anti-inflammatory drug derivative (US20200360335). This study received funding from Zhejiang Yuejia Pharmaceuticals Co., Ltd. The funder had the following involvement with the study: study design, data collection and analysis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Reviewer disclosuresPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.Author contributionsConception and design of the study: X. Yang, Z. Zhou, P. Fang, R. Zhu, J. Zhang, Z. Hou, and X. Fan. Project implementation: X. Yang, R. Zhu, L. Yang, X. Fan, Q. Yan, J. Li, Z. Zhou, and P. Fang. Data collection and analysis: X. Yang, R. Zhu, Z. Zhou, J. Zhang, Z. Hou, and P. Fang. Writing and/or revision of the manuscript: X. Yang, Z. Zhou, and P. Fang. All authors approved the final manuscript for submission.Data availability statementThe data presented in this article are not readily available because of potential intellectual property.The data that support the findings of this study are available from the corresponding author upon reasonable request.Clinical trial registrationhttp://www.chictr.org.cn.ChiCTR2000034147Correction StatementThis article has been republished with minor changes. These changes do not impact the academic content of the article.Additional informationFundingThis study received funding from Zhejiang Yuejia Pharmaceuticals Co., Ltd., and the National Science and Technology Major Projects for Major New Drugs Innovation and Development (No. 2020ZX09201-028)." @default.
• W4378781424 created "2023-06-01" @default.
• W4378781424 creator A5013617878 @default.
• W4378781424 creator A5016385021 @default.
• W4378781424 creator A5017947172 @default.
• W4378781424 creator A5023387174 @default.
• W4378781424 creator A5028556227 @default.
• W4378781424 creator A5062831729 @default.
• W4378781424 creator A5067783511 @default.
• W4378781424 creator A5069160111 @default.
• W4378781424 creator A5073445503 @default.
• W4378781424 creator A5091869334 @default.
• W4378781424 date "2023-05-30" @default.
• W4378781424 modified "2023-09-27" @default.
• W4378781424 title "First-in-human phase I studies of YJ001 spray applied to local skin in healthy subjects and patients with diabetic neuropathic pain" @default.
• W4378781424 cites W13818463 @default.
• W4378781424 cites W15585478 @default.
• W4378781424 cites W1968607405 @default.
• W4378781424 cites W1972275440 @default.
• W4378781424 cites W1974794713 @default.
• W4378781424 cites W1984010212 @default.
• W4378781424 cites W1993608591 @default.
• W4378781424 cites W2002864922 @default.
• W4378781424 cites W2014952936 @default.
• W4378781424 cites W2028513560 @default.
• W4378781424 cites W2035774809 @default.
• W4378781424 cites W2048644509 @default.
• W4378781424 cites W2064182983 @default.
• W4378781424 cites W2093652285 @default.
• W4378781424 cites W2102975358 @default.
• W4378781424 cites W2104818454 @default.
• W4378781424 cites W2121278724 @default.
• W4378781424 cites W2138407894 @default.
• W4378781424 cites W2150003943 @default.
• W4378781424 cites W2150552701 @default.
• W4378781424 cites W2168070016 @default.
• W4378781424 cites W2171553260 @default.
• W4378781424 cites W2191352991 @default.
• W4378781424 cites W2537315111 @default.
• W4378781424 cites W2740919771 @default.
• W4378781424 cites W2768334846 @default.
• W4378781424 cites W2909935573 @default.
• W4378781424 cites W3005211134 @default.
• W4378781424 cites W3182184977 @default.
• W4378781424 cites W3194956376 @default.
• W4378781424 cites W4200026682 @default.
• W4378781424 cites W4200562506 @default.
• W4378781424 doi "https://doi.org/10.1080/13543784.2023.2219388" @default.
• W4378781424 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37252861" @default.
• W4378781424 hasPublicationYear "2023" @default.
• W4378781424 type Work @default.
• W4378781424 citedByCount "1" @default.
• W4378781424 countsByYear W43787814242023 @default.
• W4378781424 crossrefType "journal-article" @default.
• W4378781424 hasAuthorship W4378781424A5013617878 @default.
• W4378781424 hasAuthorship W4378781424A5016385021 @default.
• W4378781424 hasAuthorship W4378781424A5017947172 @default.
• W4378781424 hasAuthorship W4378781424A5023387174 @default.
• W4378781424 hasAuthorship W4378781424A5028556227 @default.
• W4378781424 hasAuthorship W4378781424A5062831729 @default.
• W4378781424 hasAuthorship W4378781424A5067783511 @default.
• W4378781424 hasAuthorship W4378781424A5069160111 @default.
• W4378781424 hasAuthorship W4378781424A5073445503 @default.
• W4378781424 hasAuthorship W4378781424A5091869334 @default.
• W4378781424 hasConcept C112705442 @default.
• W4378781424 hasConcept C126322002 @default.
• W4378781424 hasConcept C142724271 @default.
• W4378781424 hasConcept C162156334 @default.
• W4378781424 hasConcept C197934379 @default.
• W4378781424 hasConcept C204787440 @default.
• W4378781424 hasConcept C27081682 @default.
• W4378781424 hasConcept C2775998707 @default.
• W4378781424 hasConcept C2777107010 @default.
• W4378781424 hasConcept C42219234 @default.
• W4378781424 hasConcept C535046627 @default.
• W4378781424 hasConcept C68122502 @default.
• W4378781424 hasConcept C71924100 @default.
• W4378781424 hasConcept C98274493 @default.
• W4378781424 hasConceptScore W4378781424C112705442 @default.
• W4378781424 hasConceptScore W4378781424C126322002 @default.
• W4378781424 hasConceptScore W4378781424C142724271 @default.
• W4378781424 hasConceptScore W4378781424C162156334 @default.
• W4378781424 hasConceptScore W4378781424C197934379 @default.
• W4378781424 hasConceptScore W4378781424C204787440 @default.
• W4378781424 hasConceptScore W4378781424C27081682 @default.
• W4378781424 hasConceptScore W4378781424C2775998707 @default.
• W4378781424 hasConceptScore W4378781424C2777107010 @default.
• W4378781424 hasConceptScore W4378781424C42219234 @default.
• W4378781424 hasConceptScore W4378781424C535046627 @default.
• W4378781424 hasConceptScore W4378781424C68122502 @default.
• W4378781424 hasConceptScore W4378781424C71924100 @default.
• W4378781424 hasConceptScore W4378781424C98274493 @default.
• W4378781424 hasIssue "6" @default.
• W4378781424 hasLocation W43787814241 @default.
• W4378781424 hasLocation W43787814242 @default.
• W4378781424 hasOpenAccess W4378781424 @default.
• W4378781424 hasPrimaryLocation W43787814241 @default.
• W4378781424 hasRelatedWork W1558033616 @default.

• next