{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T09:21:25Z","timestamp":1788254485487,"version":"build-2803163510"},"reference-count":21,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100014653","name":"Manchester Biomedical Research Centre","doi-asserted-by":"publisher","award":["NIHR203308"],"award-info":[{"award-number":["NIHR203308"]}],"id":[{"id":"10.13039\/100014653","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>S100A4 is a damage\u2010associated molecular pattern protein that amplifies pro\u2010inflammatory and pro\u2010fibrotic signalling. CAL101 is a first\u2010in\u2010class humanized monoclonal antibody that neutralizes S100A4. This first\u2010in\u2010human study evaluated safety, pharmacokinetics (PK), immunogenicity and exploratory pharmacodynamics (PD) of CAL101.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This Phase 1, randomized, double\u2010blind, placebo\u2010controlled study, included two parts. Part A assessed single ascending intravenous doses of CAL101 (0.5\u201320\u2009mg\/kg) or placebo in 40 healthy volunteers. Part B evaluated multiple ascending doses, 4 infusions of CAL101 (10 and 20\u2009mg\/kg) or placebo every 3\u2009weeks, in 17 patients with mild\u2010to\u2010moderate psoriasis. The primary endpoint was safety and tolerability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>CAL101 was well tolerated, with no dose\u2010limiting toxicities or serious adverse events. Treatment\u2010emergent adverse events were balanced between treatment groups. The PK profile showed target\u2010mediated, nonlinear kinetics at lower doses. Mean terminal half\u2010life increased from 86\u2009h at 0.5\u2009mg\/kg to 437\u2009h at 20\u2009mg\/kg after a single dose and 16\u201322\u2009days after multiple dosing. Antidrug antibodies were detected in some participants at low titers and had no effect on PK or safety. In psoriasis patients included in Part B, baseline disease severity was low (mean Psoriasis Area and Severity Index of 5.5\u20136.0). No meaningful differences in psoriasis measures were observed between CAL101 and placebo. In psoriasis lesions, CAL101 reduced tenascin C deposition and decreased pSTAT3, consistent with modulation of S100A4\u2010dependent pathways.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>CAL101 demonstrated an acceptable safety profile, predictable PK and PD effects consistent with extracellular S100A4 neutralization. These findings support further clinical development of CAL101 in fibro\u2010inflammatory diseases.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70808","type":"journal-article","created":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T09:11:50Z","timestamp":1788253910000},"source":"Crossref","is-referenced-by-count":0,"title":["A first\u2010in\u2010human study of CAL101, a monoclonal antibody targeting S100A4"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8283-0633","authenticated-orcid":false,"given":"Jonas","family":"Hall\u00e9n","sequence":"first","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia","family":"Vetrhus","sequence":"additional","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margrethe","family":"S\u00f8rgaard","sequence":"additional","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Klingelh\u00f6fer","sequence":"additional","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Signe","family":"Borchert","sequence":"additional","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Holyer","sequence":"additional","affiliation":[{"name":"Calluna Pharma AS  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruthi","family":"Ramesh","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Unit IQVIA Business  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg H. W.","family":"Distler","sequence":"additional","affiliation":[{"name":"Department of Rheumatology University Hospital D\u00fcsseldorf, Medical Faculty of Heinrich Heine University  D\u00fcsseldorf Germany"},{"name":"Hiller Research Center University Hospital D\u00fcsseldorf, Medical Faculty of Heinrich Heine University  D\u00fcsseldorf Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8918-7075","authenticated-orcid":false,"given":"Dave","family":"Singh","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Unit IQVIA Business  Manchester UK"},{"name":"Division of Immunology, Immunity to Infection and Respiratory Medicine University of Manchester, Manchester University NHS Foundation Trust  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpet.2025.103722"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14010037"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/cvr\/cvaa311"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102013\u2010204516"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/resp.13707"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard\u20102023\u2010223862"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kep316"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2009.206"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2014.07.035"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/2162402X.2018.1461301"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kead295"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.42781"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1159\/000250839"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2004.04.012"},{"key":"e_1_2_11_16_1","unstructured":"EF\u2010hand domain containing proteins introduction. 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