{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T16:28:25Z","timestamp":1759336105758,"version":"build-2065373602"},"reference-count":20,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>HT\u2010101, a liver\u2010targeted N\u2010acetylgalactosamine\u2010conjugated ribonucleic acid interference therapeutic, exhibits promising potential for the treatment of chronic hepatitis B virus infection. This randomized, double\u2010blind, placebo\u2010controlled, and single\u2010ascending\u2010dose Phase Ia study included 50 healthy volunteers. Regarding methods, 2 subjects received a single subcutaneous dose of HT\u2010101 at 25\u00a0mg, while 48 volunteers were randomized (6:2 active:placebo) in the remaining 6 cohorts to receive a single subcutaneous dose of HT\u2010101 (50\u2010800\u00a0mg) or placebo. Afterward, serial blood samples were obtained for pharmacokinetic determination across a 48\u2010hour postdose period. Safety assessments included clinical laboratory measures, vital signs, and 12\u2010lead electrocardiogram before and after dosing. As a result, plasma pharmacokinetics characterized by functional antisense strand revealed a median time to peak plasma concentration of 2.5\u20106.0\u00a0hours, and a short median plasma half\u2010life of 2.50\u20106.14\u00a0hours. It is underlined that peak and total plasma exposure to HT\u2010101 increased in a slightly greater\u2010than\u2010dose\u2010proportional manner following 25\u2010800\u00a0mg administered subcutaneously. Moreover, a single dose of HT\u2010101 at 25\u2010800\u00a0mg was safe and well tolerated in healthy Chinese volunteers. These data can support further clinical development of HT\u2010101 for hepatitis B virus infection treatment.<\/jats:p>","DOI":"10.1002\/cpdd.1569","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T10:05:07Z","timestamp":1751537107000},"page":"754-763","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Double\u2010Blind, Placebo\u2010Controlled, Single\u2010Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT\u2010101, an RNAi Therapeutic Targeting HBV Infection"],"prefix":"10.1002","volume":"14","author":[{"given":"Jianxiong","family":"Zhang","sequence":"first","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiangshuo","family":"Li","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Le","family":"Wu","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuqin","family":"Song","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao","family":"Li","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiannan","family":"Gao","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingxuan","family":"Wu","sequence":"additional","affiliation":[{"name":"Research Ward Beijing Friendship Hospital, Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong","family":"Wang","sequence":"additional","affiliation":[{"name":"Suzhou Hepa Thera Biopharmaceutical Co., Ltd.  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