{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T12:20:31Z","timestamp":1769516431191,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The objective of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of LP\u2010001 injection in healthy Chinese subjects. This was a single\u2010center, double\u2010blind, randomized, dose\u2010escalation study. Fifty\u2010six healthy adults were enrolled and randomly assigned to receive LP\u2010001 or matched placebo. A total of 156.0 drug related adverse events occurred during treatment in 38 subjects who received LP\u2010001 injection. The main events were grade 1 serum iron reduction and elevated triglycerides, which were considered related to the drug's erythropoietic effect and reversible. Pharmacokinetic exposure increased with dose (0.5\u201350 mcg\u00b7kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    ), but the increase in maximum plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and area under the plasma concentration\u2013time curve (AUC) was greater than the dose ratio (non\u2010linear). Pharmacodynamics showed dose\u2010dependent increases in hemoglobin (Hb), red blood cell count (RBC), hematocrit (HCT), and reticulocyte count (Rtc). The pharmacodynamic indicators in the 15 and 30\u00a0mcg\u00b7kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    multiple\u2010dose groups were significantly higher than those in the placebo group, and the increase in RBC count was more pronounced in the 30 mcg\u00b7kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    group. LP001, a long\u2010acting rhEPO, was safe and well\u2010tolerated at all doses in this Phase I study. These findings support its continued development as a treatment for myelodysplastic syndromes (MDS).\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70020","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T08:51:07Z","timestamp":1768812667000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["LP\u2010001, a Novel Long\u2010Acting EPO\u2010Fc Fusion Protein: A Phase I Dose\u2010Escalation Study of Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects"],"prefix":"10.1002","volume":"15","author":[{"given":"Jie","family":"Yang","sequence":"first","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University Clinical Research Hospital  Hefei Anhui China"},{"name":"Key Laboratory of Innovative Pharmaceutical Research and Clinical Evaluation Jointly Constructed by Anhui  Bengbu Anhui China"},{"name":"LongBio Pharma (Suzhou) Co., Ltd.  Suzhou Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiaxiang","family":"Ding","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University Clinical Research Hospital  Hefei Anhui China"},{"name":"Key Laboratory of Innovative Pharmaceutical Research and Clinical Evaluation Jointly Constructed by Anhui  Bengbu Anhui China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Xu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University Clinical Research Hospital  Hefei Anhui China"},{"name":"Key Laboratory of Innovative Pharmaceutical Research and Clinical Evaluation Jointly Constructed by Anhui  Bengbu Anhui China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University Clinical Research Hospital  Hefei Anhui China"},{"name":"Key Laboratory of Innovative Pharmaceutical Research and Clinical Evaluation Jointly Constructed by Anhui  Bengbu Anhui China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cuicui","family":"Han","sequence":"additional","affiliation":[{"name":"LongBio Pharma (Suzhou) Co., Ltd.  Suzhou Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heng","family":"Liu","sequence":"additional","affiliation":[{"name":"LongBio Pharma (Suzhou) Co., Ltd.  Suzhou Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huan","family":"Zhou","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University Clinical Research Hospital  Hefei Anhui China"},{"name":"Key Laboratory of Innovative Pharmaceutical Research and Clinical Evaluation Jointly Constructed by Anhui  Bengbu Anhui China"},{"name":"Clinical Trial Center of the First Affiliated Hospital of Bengbu Medical University  Bengbu Anhui China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,1,19]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/EVIDoa2200008"},{"key":"e_1_2_10_3_1","first-page":"103","article-title":"Optimizing timing and preparation for allogeneic hematopoietic stem cell transplantation in higher\u2010risk myelodysplastic syndromes","volume":"15","author":"Geng L","year":"2025","journal-title":"Blood Lymphat Cancer"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2025.0013"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.modpat.2024.100615"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm12185865"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40164-025-00678-9"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16884"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/10837450.2024.2410448"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(24)00203-5"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00874-7"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-031-92033-2_13"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.11631017"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1067\/mcp.2002.128374"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2015.02.339"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-012-9267-z"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2022.06.003"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2022.e12613"},{"issue":"9","key":"e_1_2_10_19_1","article-title":"Erythropoiesis\u2010stimulating agents (ESAs) in chronic kidney disease and cancer\u2010related anemia: a narrative review of literature","volume":"17","author":"Pothacamuri MA","year":"2025","journal-title":"Cureus"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70020","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70020","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:23:33Z","timestamp":1769264613000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/cpdd.70020"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70020","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1]]},"assertion":[{"value":"2025-11-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70020"}}