{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T02:00:24Z","timestamp":1782180024128,"version":"3.54.5"},"reference-count":22,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2010,6,1]],"date-time":"2010-06-01T00:00:00Z","timestamp":1275350400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2010,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            West Nile Virus (WNV) is a neurotropic flavivirus that can cause debilitating diseases, such as encephalitis, meningitis, or flaccid paralysis. We report the safety, pharmacokinetics, and immunogenicity of a recombinant humanized monoclonal antibody (MGAWN1) targeting the E protein of WNV in a phase 1 study, the first to be performed on humans. A single intravenous infusion of saline or of MGAWN1 at escalating doses (0.3, 1, 3, 10, or 30 mg\/kg of body weight) was administered to 40 healthy volunteers (30 receiving MGAWN1; 10 receiving placebo). Subjects were evaluated on days 0, 1, 3, 7, 14, 21, 28, 42, 56, 91, 120, and 180 by clinical assessments, clinical laboratory studies, electrocardiograms (ECGs), and pharmacokinetic and immunogenicity assays. All 40 subjects tolerated the infusion of the study drug, and 39 subjects completed the study. One serious adverse event of schizophrenia occurred in the 0.3-mg\/kg cohort. One grade 3 neutropenia occurred in the 3-mg\/kg cohort. Six MGAWN1-treated subjects experienced 11 drug-related adverse events, including diarrhea (1 subject), chest discomfort (1), oral herpes (1), rhinitis (1), neutropenia (2), leukopenia (1), dizziness (1), headache (2), and somnolence (1). In the 30-mg\/kg cohort, MGAWN1 had a half-life of 26.7 days and a maximum concentration in serum (\n            <jats:italic>C<\/jats:italic>\n            <jats:sub>max<\/jats:sub>\n            ) of 953 \u03bcg\/ml. This study suggests that single infusions of MGAWN1 up to 30 mg\/kg appear to be safe and well tolerated in healthy subjects. The\n            <jats:italic>C<\/jats:italic>\n            <jats:sub>max<\/jats:sub>\n            of 953 \u03bcg\/ml exceeds the target level in serum estimated from hamster studies by 28-fold and should provide excess WNV neutralizing activity and penetration into the brain and cerebrospinal fluid (CSF). Further evaluation of MGAWN1 for the treatment of West Nile virus infections is warranted.\n          <\/jats:p>","DOI":"10.1128\/aac.01178-09","type":"journal-article","created":{"date-parts":[[2010,3,30]],"date-time":"2010-03-30T03:55:06Z","timestamp":1269921306000},"page":"2431-2436","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":73,"title":["Safety and Pharmacokinetics of Single Intravenous Dose of MGAWN1, a Novel Monoclonal Antibody to West Nile Virus"],"prefix":"10.1128","volume":"54","author":[{"given":"John H.","family":"Beigel","sequence":"first","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey L.","family":"Nordstrom","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley R.","family":"Pillemer","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cory","family":"Roncal","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Ronald","family":"Goldwater","sequence":"additional","affiliation":[{"name":"Parexel International, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Li","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. Chris","family":"Holland","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syd","family":"Johnson","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Stein","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Koenig","sequence":"additional","affiliation":[{"name":"MacroGenics Inc., Rockville"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e31818ffd03"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1086\/376871"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/322043"},{"key":"e_1_3_2_5_2","unstructured":"West Nile virus: statistics surveillance and control 2009"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.20959"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.3109\/10428190109099335"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2008.01.001"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1086\/508293"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00147-07"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1080\/13550280801958930"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)05480-0"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1038\/nature03956"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1089\/153036604773083004"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1038\/nm1240"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2000.18.11.2349"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-137-3-200208060-00009"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2002-06-1636"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000133165.85909.08"},{"key":"e_1_3_2_20_2","first-page":"753","volume":"89","year":"2004","unstructured":"Schulz, H., H. Pels, I. Schmidt-Wolf, U. Zeelen, U. Germing, and A. Engert. 2004. Intraventricular treatment of relapsed central nervous system lymphoma with the anti-CD20 antibody rituximab. Haematologica89:753-754.","journal-title":"Haematologica"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.501"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1086\/430708"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.ppat.1000453"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.01178-09","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.01178-09","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T20:15:36Z","timestamp":1645474536000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.01178-09"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,6]]},"references-count":22,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2010,6]]}},"alternative-id":["10.1128\/AAC.01178-09"],"URL":"https:\/\/doi.org\/10.1128\/aac.01178-09","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,6]]},"assertion":[{"value":"2009-08-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2010-03-10","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2010-06-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}