{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T02:14:05Z","timestamp":1781576045566,"version":"3.54.5"},"reference-count":21,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2016,5,1]],"date-time":"2016-05-01T00:00:00Z","timestamp":1462060800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>Human cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the function of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. Here, we evaluated the safety, tolerability, and pharmacokinetics of a single intravenous dose of LJP538 or LJP539 or their combination in healthy volunteers. Adverse events and laboratory abnormalities occurred sporadically with similar incidence between antibody and placebo groups and without any apparent relationship to dose. No subject who received antibody developed a hypersensitivity, infusion-related reaction or anti-drug antibodies. After intravenous administration, both LJP538 and LJP539 demonstrated typical human IgG1 pharmacokinetic properties, with slow clearances, limited volumes of distribution, and long terminal half-lives. The pharmacokinetic parameters were linear and dose proportional for both antibodies across the 50-fold range of doses evaluated in the study. There was no apparent impact on pharmacokinetics when the antibodies were administered alone or in combination. CSJ148 and the individual monoclonal antibodies were safe and well tolerated, with pharmacokinetics as expected for human immunoglobulin.<\/jats:p>","DOI":"10.1128\/aac.02698-15","type":"journal-article","created":{"date-parts":[[2016,3,1]],"date-time":"2016-03-01T04:04:31Z","timestamp":1456805071000},"page":"2881-2887","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":26,"title":["A First-in-Human Study To Assess the Safety and Pharmacokinetics of Monoclonal Antibodies against Human Cytomegalovirus in Healthy Volunteers"],"prefix":"10.1128","volume":"60","author":[{"given":"Kiran","family":"Dole","sequence":"first","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florencia Pereyra","family":"Segal","sequence":"additional","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Feire","sequence":"additional","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"},{"name":"Novartis Institutes for BioMedical Research, Emeryville, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baldur","family":"Magnusson","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan C.","family":"Rondon","sequence":"additional","affiliation":[{"name":"Elite Research Institute, Miami, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janardhana","family":"Vemula","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Yu","sequence":"additional","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinuo","family":"Pang","sequence":"additional","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Pertel","sequence":"additional","affiliation":[{"name":"Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-007-0066-x"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2006.05.002"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/590934"},{"key":"e_1_3_2_5_2","doi-asserted-by":"crossref","first-page":"S839","DOI":"10.1093\/clinids\/12.Supplement_7.S839","article-title":"Cytomegalovirus immunoglobulins in the prevention and treatment of cytomegalovirus disease","volume":"12","author":"Snydman DR","year":"1990","unstructured":"Snydman DR. 1990. Cytomegalovirus immunoglobulins in the prevention and treatment of cytomegalovirus disease. Rev Infect Dis 12(Suppl 7):S839\u2013S848.","journal-title":"Rev Infect Dis"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198710223171703"},{"key":"e_1_3_2_7_2","volume-title":"Phase 2 randomized, double-blind, placebo-controlled trial of RG7667 for prevention of cytomegalovirus infection in high-risk kidney transplant recipients","author":"Ishida JH","year":"2015","unstructured":"Ishida JH, Patel A, McBride J, Burgess T, Derby MA, Emu B, Feierbach B, Liao XC, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Tavel JA. 2015. Phase 2 randomized, double-blind, placebo-controlled trial of RG7667 for prevention of cytomegalovirus infection in high-risk kidney transplant recipients. Abstr 55th Intersci Conf Antimicrob Agents Chemother, San Diego, CA."},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.01809-09"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/165.2.381"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.09.056"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.00467-12"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026451721686"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.78.18.10023-10033.2004"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0509201102"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.humimm.2005.01.029"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-011-9256-y"},{"key":"e_1_3_2_17_2","first-page":"679","article-title":"Pharmacokinetics of cytomegalovirus specific IgG antibody following intravenous immunoglobulin in bone marrow transplant patients","volume":"4","author":"Rand KH","year":"1989","unstructured":"Rand KH, Houck H, Ganju A, Babington RG, Elfenbein GJ. 1989. Pharmacokinetics of cytomegalovirus specific IgG antibody following intravenous immunoglobulin in bone marrow transplant patients. Bone Marrow Transpl 4:679\u2013683.","journal-title":"Bone Marrow Transpl"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1002\/j.1552-4604.1991.tb03688.x"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1592\/phco.20.15.1175.34592"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1083-8791(01)80005-7"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1177\/00912700022009477"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-198411000-00026"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02698-15","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02698-15","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T20:46:53Z","timestamp":1645476413000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.02698-15"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,5]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,5]]}},"alternative-id":["10.1128\/AAC.02698-15"],"URL":"https:\/\/doi.org\/10.1128\/aac.02698-15","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,5]]},"assertion":[{"value":"2015-11-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-02-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-04-22","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}