{"id":"https://openalex.org/W7128490201","doi":"https://doi.org/10.6084/m9.figshare.31305492","title":"Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study","display_name":"Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study","publication_year":2026,"publication_date":"2026-02-10","ids":{"openalex":"https://openalex.org/W7128490201","doi":"https://doi.org/10.6084/m9.figshare.31305492"},"language":"en","primary_location":{"id":"doi:10.6084/m9.figshare.31305492","doi":"https://doi.org/10.6084/m9.figshare.31305492","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31305492","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.6084/m9.figshare.31305492","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5110349851","display_name":"Tomoko Hasunuma","orcid":"https://orcid.org/0000-0001-6241-7985","observed_orcids":["https://orcid.org/0000-0001-6241-7985"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Hasunuma, Tomoko","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042617470","display_name":"Michio Yagi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Yagi, Michio","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5125543786","display_name":"Noboru Nakamichi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Nakamichi, Noboru","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5125584900","display_name":"Andrew Blauvelt","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Blauvelt, Andrew","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5085831636","display_name":"Diamant Tha\u00e7i","orcid":"https://orcid.org/0000-0001-8513-550X","observed_orcids":["https://orcid.org/0000-0001-8513-550X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Tha\u00e7i, Diamant","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5110545230","display_name":"JeeHye Suh","orcid":"https://orcid.org/0009-0005-9273-0784","observed_orcids":["https://orcid.org/0009-0005-9273-0784"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Suh, JeeHye","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5055582974","display_name":"JungBin Cha","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Cha, JungBin","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5125543775","display_name":"IIn Noh","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Noh, IIn","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5125505601","display_name":"EunKyung Lee","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Lee, EunKyung","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5125523741","display_name":"Kim A. Papp","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Papp, Kim A.","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10469","display_name":"Psoriasis: Treatment and Pathogenesis","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/secukinumab","display_name":"secukinumab","score":0.9959999918937683},{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.9490000009536743},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9139999747276306},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.9100000262260437},{"id":"https://openalex.org/keywords/safety","display_name":"safety","score":0.48500001430511475},{"id":"https://openalex.org/keywords/tnf-alpha-inhibitors","display_name":"TNF-alpha inhibitors","score":0.6320000290870667},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.6259999871253967},{"id":"https://openalex.org/keywords/single-dose-administration","display_name":"single-dose administration","score":0.6439999938011169},{"id":"https://openalex.org/keywords/neutralizing-antibodies","display_name":"neutralizing antibodies","score":0.6679999828338623},{"id":"https://openalex.org/keywords/japanese-men","display_name":"Japanese men","score":0.4359999895095825},{"id":"https://openalex.org/keywords/drug-equivalence","display_name":"drug equivalence","score":0.4189999997615814},{"id":"https://openalex.org/keywords/treatment-emergent-adverse-events","display_name":"treatment-emergent adverse events","score":0.8389999866485596},{"id":"https://openalex.org/keywords/inflammatory-diseases","display_name":"inflammatory diseases","score":0.4259999990463257},{"id":"https://openalex.org/keywords/biologic-medicines","display_name":"biologic medicines","score":0.4099999964237213},{"id":"https://openalex.org/keywords/healthcare-cost-reduction","display_name":"healthcare cost reduction","score":0.3779999911785126},{"id":"https://openalex.org/keywords/access-to-medicines","display_name":"access to medicines","score":0.5320000052452087}],"concepts":[{"id":"https://openalex.org/C2779786854","wikidata":"https://www.wikidata.org/wiki/Q7444755","display_name":"Secukinumab","level":4,"score":0.9352999925613403},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8410000205039978},{"id":"https://openalex.org/C2780868878","wikidata":"https://www.wikidata.org/wiki/Q1660197","display_name":"Immunogenicity","level":3,"score":0.7753999829292297},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6743000149726868},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.5781999826431274},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.5376999974250793},{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.527400016784668},{"id":"https://openalex.org/C3018359032","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Safety profile","level":3,"score":0.45989999175071716},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.4174000024795532},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.4011000096797943},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.3871000111103058},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.3693999946117401},{"id":"https://openalex.org/C111113717","wikidata":"https://www.wikidata.org/wiki/Q725307","display_name":"Pharmacodynamics","level":3,"score":0.34060001373291016},{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.325300008058548},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.30410000681877136},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.3001999855041504},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.29339998960494995},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.2816999852657318},{"id":"https://openalex.org/C8891405","wikidata":"https://www.wikidata.org/wiki/Q1059","display_name":"Immune system","level":2,"score":0.2603999972343445},{"id":"https://openalex.org/C57658597","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Pharmacovigilance","level":3,"score":0.2524000108242035},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.25209999084472656}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.6084/m9.figshare.31305492","doi":"https://doi.org/10.6084/m9.figshare.31305492","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31305492","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.6084/m9.figshare.31305492.v1","doi":"https://doi.org/10.6084/m9.figshare.31305492.v1","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31305492.v1","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.6084/m9.figshare.31305492.v2","doi":"https://doi.org/10.6084/m9.figshare.31305492.v2","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31305492.v2","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"}],"best_oa_location":{"id":"doi:10.6084/m9.figshare.31305492","doi":"https://doi.org/10.6084/m9.figshare.31305492","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31305492","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"sustainable_development_goals":[{"score":1.0,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Randomized Controlled Trial","id":"https://openalex.org/study-designs/randomized-controlled-trial"},{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W7061523238","https://openalex.org/W4403498878","https://openalex.org/W6958496842","https://openalex.org/W4385073877","https://openalex.org/W6958346467","https://openalex.org/W2480028188","https://openalex.org/W2921716909","https://openalex.org/W4379648580","https://openalex.org/W4399484120","https://openalex.org/W3107011196"],"abstract_inverted_index":{"This":[0,280,320],"first-in-human":[1],"study":[2,32,196,321,337,378],"compared":[3],"the":[4,65,106,118,216,266,302,307,327,381,384,387,408],"pharmacokinetics,":[5],"safety,":[6],"and":[7,18,74,95,114,176,181,286,399,431],"immunogenicity":[8,177,400],"of":[9,54,112,153,253,368,389,395,418],"candidate":[10],"biosimilar":[11,314,417],"CT-P55":[12,154,167,331,342,390,413,430],"to":[13,48,71,157,178,209,259,290,299,339,345,350,393,426],"both":[14,158,179],"European":[15,303],"Union":[16,304],"(EU)-approved":[17],"United":[19,308],"States":[20,309],"(US)-licensed":[21],"secukinumab":[22,91,97,147,160,183,296,347,433],"in":[23,37,184,214,301,334,435],"healthy":[24,185,351],"participants.":[25],"Three-arm,":[26],"double-blinded,":[27],"parallel-group,":[28],"single-dose,":[29],"Phase":[30],"1":[31],"conducted":[33],"across":[34,84],"four":[35],"centers":[36],"Japan":[38],"over":[39],"22":[40],"weeks.":[41],"Healthy":[42],"adult":[43],"males":[44],"were":[45,62,82,116,124,130,137,355,391,404],"randomized":[46],"(1:1:1)":[47],"a":[49,204,229,236,251,312,365,415],"single":[50,366],"150-mg":[51],"subcutaneous":[52],"dose":[53],"CTP55,":[55],"EU-approved,":[56],"or":[57,306,373],"US-licensed":[58,96,182],"secukinumab.":[59,376,397,419],"Primary":[60],"endpoints":[61],"area":[63],"under":[64],"concentration\u2013time":[66],"curve":[67],"from":[68,240],"time":[69,329],"zero":[70],"infinity":[72],"(AUC0\u2013inf)":[73],"maximum":[75],"serum":[76],"drug":[77],"concentration":[78],"(Cmax).":[79],"Baseline":[80],"characteristics":[81],"comparable":[83,156,174,406],"groups":[85,359],"(CT-P55":[86],"[n":[87,92,98],"=":[88,93,99],"57],":[89],"EU-approved":[90,180],"59],":[94],"56]).":[100],"The":[101,149,195,336,377],"90%":[102],"confidence":[103],"intervals":[104],"for":[105,132,288],"geometric":[107],"least":[108],"squares":[109],"mean":[110,282],"ratios":[111],"AUC0\u2013inf":[113],"Cmax":[115],"within":[117],"equivalence":[119],"margin":[120],"(80\u2013125%).":[121],"Safety":[122,398],"profiles":[123],"comparable.":[125],"218":[126],"treatment-emergent":[127],"adverse":[128,142],"events":[129],"reported":[131,145],"110":[133],"(65.5%)":[134],"participants;":[135],"most":[136],"Grade":[138],"1/2.":[139],"One":[140],"serious":[141],"event":[143],"was":[144,155,326,332],"(US-licensed":[146],"group).":[148],"low":[150],"immunogenic":[151],"profile":[152],"reference":[159,274,346],"groups,":[161],"with":[162,437],"no":[163,295],"neutralizing":[164],"antibodies":[165],"detected.":[166],"exhibited":[168],"equivalent":[169,344,392],"pharmacokinetics":[170,382],"as":[171,173,265,414],"well":[172,429],"safety":[175],"Japanese":[186],"males.":[187,194],"Generalizability":[188],"may":[189],"be":[190,246],"limited":[191],"beyond":[192],"Asian":[193],"is":[197,203,207,218,228,235,250,256,284,317,322,343,424],"registered":[198],"at":[199,360],"Clinicaltrials.gov":[200],"(NCT07054970).":[201],"Secukinumab":[202,227],"medicine":[205,238,254,263],"that":[206,255,330,341,380],"used":[208],"treat":[210],"some":[211],"inflammatory":[212,439],"diseases,":[213],"which":[215,232],"body":[217,385],"harmed":[219],"by":[220],"its":[221],"own":[222],"immune":[223,402],"system":[224],"(natural":[225],"defenses).":[226],"\u2018biologic\u2019":[230],"medicine,":[231],"means":[233],"it":[234,325],"complex":[237],"made":[239],"living":[241],"cells.":[242],"Biologic":[243],"medicines":[244,275],"can":[245,281],"expensive.":[247],"A":[248,420],"\u2018biosimilar\u2019":[249],"type":[252],"very":[257],"similar":[258,278],"an":[260,438],"existing":[261],"biologic":[262],"(known":[264],"\u2018reference\u2019":[267,371,375,396,432],"biologic).":[268],"Biosimilars":[269],"are":[270,294],"typically":[271],"cheaper":[272,285],"than":[273],"yet":[276],"provide":[277],"results.":[279],"treatment":[283],"easier":[287],"patients":[289,300,436],"access.":[291],"Currently,":[292],"there":[293],"biosimilars":[297],"available":[298],"(EU)":[305],"(US),":[310],"but":[311],"potential":[313,416],"called":[315],"\u2018CTP55\u2019":[316],"being":[318],"developed.":[319],"important":[323],"because":[324],"first":[328],"tested":[333],"humans.":[335],"aimed":[338],"show":[340],"when":[348],"given":[349],"adults.":[352],"Study":[353],"participants":[354],"split":[356],"into":[357],"three":[358],"random.":[361],"Each":[362],"group":[363],"received":[364],"injection":[367],"CT-P55,":[369],"EU":[370],"secukinumab,":[372],"US":[374],"showed":[379],"(how":[383],"processes":[386],"drug)":[388],"those":[394],"(unwanted":[401],"reactions)":[403],"also":[405],"between":[407],"treatments.":[409],"These":[410],"results":[411],"support":[412],"new":[421],"clinical":[422],"trial":[423],"underway":[425],"compare":[427],"how":[428],"work":[434],"disease.":[440]},"counts_by_year":[],"updated_date":"2026-11-11T12:16:26.678958","created_date":"2026-02-11T00:00:00"}