{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T17:29:33Z","timestamp":1772126973913,"version":"3.50.1"},"reference-count":14,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,1,25]],"date-time":"2021-01-25T00:00:00Z","timestamp":1611532800000},"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":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>SYN023 is a mixture of 2 humanized monoclonal antirabies antibodies (CTB011, CTB012). Two first\u2010in\u2010human studies evaluated ascending intramuscular (IM) injected doses (Study SYN023\u2010001; N = 15) and IM vs subcutaneous (SC) administration (Study SYN023\u2010003; N = 35) in healthy adults. In both studies, end points were safety, pharmacokinetics (PK), pharmacodynamics\/rabies virus neutralizing activity (RVNA), and immunogenicity (anti\u2010SYN023 antibodies). Adverse events were mild and infrequent at all doses tested by IM injection (0.3\u00a0mg\/kg, 1.0\u00a0mg\/kg, 2.0\u00a0mg\/kg), or by SC injection (0.3\u00a0mg\/kg). There were no apparent trends in adverse event frequency or nature with increased dose or with administration route. Serum PK of SYN023 component antibodies appeared comparable to each other at each dose tested and when administered IM versus SC with serum exposure doubling over the second week after administration. At the lowest dose tested (0.3\u00a0mg\/kg) by either IM or SC injection, RVNA levels exceeded the concentration generally accepted as protective against rabies (\u22650.5\u00a0IU\/mL) by day 1 after administration. Supra\u2010inhibitory levels persisted &gt;42 days. RVNA increased with higher doses. Anti\u2010CTB011 and anti\u2010CTB012 antibodies occurred with no apparent effect on PK or safety. These data support the potential use of SYN023 in antirabies postexposure prophylaxis.<\/jats:p>","DOI":"10.1002\/cpdd.917","type":"journal-article","created":{"date-parts":[[2021,1,25]],"date-time":"2021-01-25T22:43:51Z","timestamp":1611614631000},"page":"807-817","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Safety, Pharmacokinetics, and Neutralizing Activity of SYN023, a Mixture of Two Novel Antirabies Monoclonal Antibodies Intended for Use in Postrabies Exposure Prophylaxis"],"prefix":"10.1002","volume":"10","author":[{"given":"J. Bruce","family":"McClain","sequence":"first","affiliation":[{"name":"Synermore Biologics Co. Ltd  Taipei City Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ariel","family":"Chuang","sequence":"additional","affiliation":[{"name":"Synermore Biologics Co. Ltd  Taipei City Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan M.","family":"Moore","sequence":"additional","affiliation":[{"name":"Rabies Laboratory Kansas State Veterinary Diagnostic Laboratory Kansas State University  Manhattan Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Tsao","sequence":"additional","affiliation":[{"name":"Synermore Biologics Co. 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