{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T22:34:05Z","timestamp":1793054045929,"version":"4.5.0"},"reference-count":24,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T00:00:00Z","timestamp":1681344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> Salvianolic acid B (Sal B) is one of the main active ingredients of <jats:ext-link>Sa<jats:italic>lvia miltiorrhiza<\/jats:italic> Bunge<\/jats:ext-link>. In China, many traditional Chinese medicines have been modified into injections for higher bioavailability and better efficacy. Salvianolic acid injection has been widely used in the clinic.<\/jats:p><jats:p><jats:bold>Objective:<\/jats:bold> This phase 1, randomized, double-blind, placebo-controlled, single-center study aimed to evaluate the safety, tolerance, and pharmacokinetics of Sal B injection in healthy Chinese volunteers.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> For the single-ascending-dose study, forty-seven healthy volunteers were randomly divided into 25, 75, 150, 200, 250, and 300\u00a0mg groups. For the multiple-ascending-dose study, sixteen healthy volunteers were randomly divided into 150 and 300\u00a0mg groups. In each group, volunteers were treated with Sal B or placebo randomly. Their safety was evaluated by a skin test, physical examination, vital sign, laboratory examination, 12-lead electrocardiogram, Holter, and clinical symptoms and signs. Blood samples were collected in 75, 150, and 300\u00a0mg single-ascending-dose study groups and 150\u00a0mg multiple-ascending-dose study groups to determine the concentration of salvianolic acid B.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> In single-ascending-dose study groups, there were 41 adverse events in 24 cases (51.1%, 24\/47). In multiple-ascending-dose study groups, there were 13 adverse events in eight cases (50.0%, 8\/16). Sixty-six volunteers received the skin test, and three of them were excluded because of the positive result. Adverse events related to the treatment included increased alanine aminotransferase (4.0%), increased bilirubin (2.0%), increased creatinine kinase-MB (2.0%), increased brain natriuretic peptide (8.0%), increased urine N-acetyl-\u03b2-D-glucosidase (4.0%), dizziness (2.0%), and chest discomfort (2.0%). No serious adverse events occurred. No volunteers withdrew from the trial. Peak plasma concentration and the area under the plasma concentration\u2013time curve of salvianolic acid B progressively increased in a dose-dependent manner in 75, 150, and 300\u00a0mg single-ascending-dose study groups. There was no accumulation after 5 consecutive days of administration of 150\u00a0mg salvianolic acid B.<\/jats:p><jats:p><jats:bold>Conclusion:<\/jats:bold> Salvianolic acid B injections administered up to 300\u00a0mg in a single dose and 250\u00a0mg for 5 consecutive days showed excellent safety and tolerability in healthy Chinese volunteers.<\/jats:p><jats:p><jats:bold>Clinical Trial Registration:<\/jats:bold><jats:ext-link>www.chinadrugtrials.org.cn<\/jats:ext-link>, identifier CTR20192236<\/jats:p>","DOI":"10.3389\/fphar.2023.1146309","type":"journal-article","created":{"date-parts":[[2023,4,14]],"date-time":"2023-04-14T07:45:31Z","timestamp":1681458331000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":33,"title":["Safety, tolerance, and pharmacokinetics of salvianolic acid B in healthy Chinese volunteers: A randomized, double-blind, placebo-controlled phase 1 clinical trial"],"prefix":"10.3389","volume":"14","author":[{"given":"Junlin","family":"Cheng","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingjing","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Le","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunfang","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianghui","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Runze","family":"Qiu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhibin","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongwei","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,4,13]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"739","DOI":"10.21037\/atm-21-4779","article-title":"Salvianolic acid B alleviates neurological injury by upregulating stanniocalcin 1 expression","volume":"10","author":"Bi","year":"2022","journal-title":"Ann. 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