{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T13:02:05Z","timestamp":1790341325300,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:00:00Z","timestamp":1788998400000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"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":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>HP501, a novel highly selective renal urate transporter 1 (URAT1) inhibitor, represents a promising therapeutic option for hyperuricemia. This Phase I study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HP501 in Chinese gout patients. 37 patients with gout and hyperuricemia were enrolled in this single\u2010center, open\u2010label, dose\u2010escalation study. Participants were sequentially assigned to receive HP501 at 60, 80, and 100\u00a0mg twice daily (BID) following single\u2010 and multiple\u2010dose regimens. Safety assessments, PK parameters, and PD reductions were systematically evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>HP501 demonstrated an acceptable safety and tolerability profile across all dose cohorts. The most common adverse events (\u226510% of patients) included gout flare (36.1%), prostatic hypertrophy (36.1%), elevated ALT (16.7%), and kidney stones (11.1%), all of which were mild to moderate in severity. PK analysis revealed dose\u2010proportional increases in Cmax and AUC (60 to 100\u00a0mg BID), with corresponding dose\u2010dependent reductions in serum UA levels. All patients achieved therapeutic UA targets (&lt;360\u00a0\u00b5mol\/L).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>These findings support the clinical advancement of HP501, with 60 to 100\u00a0mg BID identified as the recommended dose range for further investigation in subsequent trials. However, these findings are preliminary and limited by the single\u2010center design, small sample size, and exclusion of female patients, warranting confirmation in larger, more diverse populations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cpdd.70101","type":"journal-article","created":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T07:31:17Z","timestamp":1789025477000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Dose\u2010Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HP501 in Male Chinese Gout Patients with Hyperuricemia"],"prefix":"10.1002","volume":"15","author":[{"given":"Longxia","family":"Chen","sequence":"first","affiliation":[{"name":"Institute of Drug Clinical Trial\/GCP Center The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruilin","family":"Ding","sequence":"additional","affiliation":[{"name":"Institute of Drug Clinical Trial\/GCP Center The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanwei","family":"Chen","sequence":"additional","affiliation":[{"name":"Hinova Pharmaceuticals Inc.  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinghai","family":"Li","sequence":"additional","affiliation":[{"name":"Hinova Pharmaceuticals Inc.  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tengqiong","family":"Xiong","sequence":"additional","affiliation":[{"name":"Institute of Drug Clinical Trial\/GCP Center The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Chen","sequence":"additional","affiliation":[{"name":"Institute of Drug Clinical Trial\/GCP Center The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaojing","family":"Hu","sequence":"additional","affiliation":[{"name":"Institute of Drug Clinical Trial\/GCP Center The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Zhou","sequence":"additional","affiliation":[{"name":"Hinova Pharmaceuticals Inc.  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Cardiology The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Cardiology The Affiliated Hospital of Southwest Medical University  Luzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-018-22570-9"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2478\/jtim-2022-0031"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584-020-0441-1"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/762820"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2018.00160"},{"issue":"9","key":"e_1_2_10_7_1","first-page":"533","article-title":"Gout: rapid evidence review","volume":"102","author":"Clebak KT","year":"2020","journal-title":"Am Fam Physician"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41008"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000861"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543776.2022.2165911"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-016-1107-x"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2019.1594771"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2875-11-39"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0676.1995.tb00102.x"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2017.1401609"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgac032"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-023-49052-x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.12998\/wjcc.v7.i13.1717"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-023-01274-7"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/key245"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.4c00136"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.42927"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00569-9"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70101","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70101","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70101","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T12:40:34Z","timestamp":1790340034000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70101"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":22,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/cpdd.70101"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70101","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"2026-02-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70101"}}