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Protective antigen (PA) is a critical component required for the virulence of <jats:italic>Bacillus anthracis<\/jats:italic>. Obiltoxaximab, a high\u2010affinity monoclonal antibody that neutralizes PA, is approved in the United States for intravenous use for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or appropriate. Here, we explored the safety, pharmacokinetics (PK), and immunogenicity of obiltoxaximab administered by intramuscular injection at doses of 4, 8, 16, 20, and 24 mg\/kg in healthy humans. Systemic exposures were approximately dose proportional, maximum serum concentrations were observed after 6\u20139 days, and terminal half\u2010life ranged from 16 to 23 days. Average absolute intramuscular bioavailability was 64%. Obiltoxaximab was well tolerated, and local tolerability was acceptable up to 24 mg\/kg intramuscularly, up to 6 injections per dose, and up to 5 mL per injection. No injection\u2010site abscesses or hypersensitivity reactions occurred; no subjects developed treatment\u2010emergent antitherapeutic antibodies over the study period of 71 days.<\/jats:p>","DOI":"10.1002\/cpdd.410","type":"journal-article","created":{"date-parts":[[2017,11,10]],"date-time":"2017-11-10T16:23:13Z","timestamp":1510330993000},"page":"652-660","source":"Crossref","is-referenced-by-count":19,"title":["Safety, Pharmacokinetics, and Immunogenicity of Obiltoxaximab After Intramuscular Administration to Healthy Humans"],"prefix":"10.1002","volume":"7","author":[{"given":"Christa F.","family":"Nagy","sequence":"first","affiliation":[{"name":"Department of Clinical Operations Elusys Therapeutics Inc.  Pine Brook NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy S.","family":"Leach","sequence":"additional","affiliation":[{"name":"InterimMD Inc.  Groton MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"King","sequence":"additional","affiliation":[{"name":"Covance Clinical Research Unit Inc.  Dallas TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Guttendorf","sequence":"additional","affiliation":[{"name":"Aclairo Pharmaceutical Development Group Inc.  Vienna VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,11,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199909093411107"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.micro.55.1.647"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid0706.010604"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9440(10)63697-8"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.17.2236"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-144-4-200602210-00009"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2002.130687"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.90.6.2291"},{"key":"e_1_2_9_10_1","unstructured":"FDA Product Development Under the Animal Rule:Guidance for Industry. 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