{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T13:37:17Z","timestamp":1769521037469,"version":"3.49.0"},"reference-count":21,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T00:00:00Z","timestamp":1768521600000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Guselkumab is approved for the treatment of psoriasis, psoriatic arthritis, as well as ulcerative colitis and Crohn's disease. Two delivery devices for subcutaneous (SC) injection previously had been approved for the administration of 100\u00a0mg guselkumab. This study was designed to demonstrate the bioequivalence and tolerability of guselkumab following a single\u2010dose SC administration of 100\u00a0mg guselkumab using a 1\u00a0mL prefilled syringe (PFS) assembled with an Ypsomate autoinjector (i.e., 1\u00a0mL PFS\u2010Y, Test device) as compared to the approved 1\u00a0mL PFS assembled with the UltraSafe Plus needle safety guard (i.e., 1\u00a0mL PFS\u2010U, Reference device). Mean serum guselkumab concentration\u2013time profiles were nearly superimposable for both devices following a single SC injection. The geometric mean ratios and the corresponding 90% confidence interval [CI] for C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    were 102.28% (94.85%\u2013110.30%) and 102.10% (95.19%\u2013109.51%), respectively. There were no significant differences in the incidence of treatment\u2010emergent adverse events between the two treatment groups, and the incidence of treatment\u2010emergent anti\u2010drug antibodies was low and comparable between the two groups. Overall, these results suggest that the pharmacokinetics, safety\/tolerability, and immunogenicity of guselkumab are comparable when administered via the 1\u00a0mL PFS\u2010Y and 1\u00a0mL PFS\u2010U.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70007","type":"journal-article","created":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T04:05:16Z","timestamp":1768622716000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1 Bioequivalence Study to Assess the Pharmacokinetics, Safety and Tolerability of Guselkumab After a Single\u2010Dose Administration via Two Subcutaneous Injection Devices in Healthy Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Angela","family":"Jeong","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathleen","family":"Weisel","sequence":"additional","affiliation":[{"name":"Immunology Clinical Development Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dessislava","family":"Dimitrova","sequence":"additional","affiliation":[{"name":"Immunology Clinical Development Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brianna","family":"Donnelly","sequence":"additional","affiliation":[{"name":"Preclinical Sciences &amp; Translational Safety Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Wang","sequence":"additional","affiliation":[{"name":"Statistics &amp; Decision Science Johnson &amp; Johnson  Titusville NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"An","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics Johnson &amp; Johnson  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhenhua","family":"Xu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,1,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1063"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.0900036"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1000600"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm.3895"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2014.146"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2008.03.004"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/441166a"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.041"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.042"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30265-8"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30263-4"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(25)00681-6"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2025.02.033"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01927-5"},{"key":"e_1_2_10_16_1","volume-title":"TREMFYA (guselkumab) Prescribing Information"},{"key":"e_1_2_10_17_1","volume-title":"Guidance for Industry","author":"FDA"},{"key":"e_1_2_10_18_1","volume-title":"Multi\u2010discipline review of guselkumab BLA 761061","author":"FDA"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-016-2110-5"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1080\/09546634.2019.1587145"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15364"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13197"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70007","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70007","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70007","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:23:30Z","timestamp":1769264610000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70007"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/cpdd.70007"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70007","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1]]},"assertion":[{"value":"2025-10-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70007"}}