{"id":"https://openalex.org/W7128906142","doi":"https://doi.org/10.26442/00403660.2025.12.203550","title":"Safety, tolerability, and pharmacokinetics of verenafusp alfa in healthy volunteers: results of an open-label multicohort phase I study","display_name":"Safety, tolerability, and pharmacokinetics of verenafusp alfa in healthy volunteers: results of an open-label multicohort phase I study","publication_year":2026,"publication_date":"2026-02-14","ids":{"openalex":"https://openalex.org/W7128906142","doi":"https://doi.org/10.26442/00403660.2025.12.203550","pmid":"https://pubmed.ncbi.nlm.nih.gov/41705613"},"language":"ru","primary_location":{"id":"doi:10.26442/00403660.2025.12.203550","doi":"https://doi.org/10.26442/00403660.2025.12.203550","is_oa":true,"landing_page_url":"https://doi.org/10.26442/00403660.2025.12.203550","pdf_url":"https://ter-arkhiv.ru/0040-3660/article/download/696567/219049","source":{"id":"https://openalex.org/S27897580","display_name":"Terapevticheskii arkhiv","issn_l":"0040-3660","issn":["0040-3660","2309-5342"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jufo-1","medline","norway-1","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4320800547","host_organization_name":"Consilium Medicum","host_organization_lineage":["https://openalex.org/P4320800547"],"host_organization_lineage_names":["Consilium Medicum"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Terapevticheskii arkhiv","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://ter-arkhiv.ru/0040-3660/article/download/696567/219049","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5121005834","display_name":"Elena A. Smolyarchuk","orcid":"https://orcid.org/0000-0002-2615-7167","observed_orcids":["https://orcid.org/0000-0002-2615-7167"]},"institutions":[{"id":"https://openalex.org/I17877952","display_name":"Sechenov University","ror":"https://ror.org/02yqqv993","country_code":"RU","type":"education","lineage":["https://openalex.org/I17877952"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Elena A. Smolyarchuk","raw_affiliation_strings":["Sechenov First Moscow State Medical University (Sechenov University)"],"raw_orcid":"https://orcid.org/0000-0002-2615-7167","affiliations":[{"raw_affiliation_string":"Sechenov First Moscow State Medical University (Sechenov University)","institution_ids":["https://openalex.org/I17877952"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061459239","display_name":"Susanna Sergeevna Sologova","orcid":"https://orcid.org/0000-0002-8526-7147","observed_orcids":["https://orcid.org/0000-0002-8526-7147"]},"institutions":[{"id":"https://openalex.org/I17877952","display_name":"Sechenov University","ror":"https://ror.org/02yqqv993","country_code":"RU","type":"education","lineage":["https://openalex.org/I17877952"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Susanna S. Sologova","raw_affiliation_strings":["Sechenov First Moscow State Medical University (Sechenov University)"],"raw_orcid":"https://orcid.org/0000-0002-8526-7147","affiliations":[{"raw_affiliation_string":"Sechenov First Moscow State Medical University (Sechenov University)","institution_ids":["https://openalex.org/I17877952"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5098161171","display_name":"Anna V. Bushmanova","orcid":"https://orcid.org/0009-0003-2969-5408","observed_orcids":["https://orcid.org/0009-0003-2969-5408"]},"institutions":[{"id":"https://openalex.org/I17877952","display_name":"Sechenov University","ror":"https://ror.org/02yqqv993","country_code":"RU","type":"education","lineage":["https://openalex.org/I17877952"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Anna V. Bushmanova","raw_affiliation_strings":["Sechenov First Moscow State Medical University (Sechenov University)"],"raw_orcid":"https://orcid.org/0009-0003-2969-5408","affiliations":[{"raw_affiliation_string":"Sechenov First Moscow State Medical University (Sechenov University)","institution_ids":["https://openalex.org/I17877952"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5126018401","display_name":"Giunai Z. Asadova","orcid":"https://orcid.org/0009-0008-6479-5734","observed_orcids":["https://orcid.org/0009-0008-6479-5734"]},"institutions":[{"id":"https://openalex.org/I17877952","display_name":"Sechenov University","ror":"https://ror.org/02yqqv993","country_code":"RU","type":"education","lineage":["https://openalex.org/I17877952"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Giunai Z. Asadova","raw_affiliation_strings":["Sechenov First Moscow State Medical University (Sechenov University)"],"raw_orcid":"https://orcid.org/0009-0008-6479-5734","affiliations":[{"raw_affiliation_string":"Sechenov First Moscow State Medical University (Sechenov University)","institution_ids":["https://openalex.org/I17877952"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5126002526","display_name":"Irina D. Savostina","orcid":"https://orcid.org/0009-0007-9707-2623","observed_orcids":["https://orcid.org/0009-0007-9707-2623"]},"institutions":[{"id":"https://openalex.org/I17877952","display_name":"Sechenov University","ror":"https://ror.org/02yqqv993","country_code":"RU","type":"education","lineage":["https://openalex.org/I17877952"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Irina D. Savostina","raw_affiliation_strings":["Sechenov First Moscow State Medical University (Sechenov University)"],"raw_orcid":"https://orcid.org/0009-0007-9707-2623","affiliations":[{"raw_affiliation_string":"Sechenov First Moscow State Medical University (Sechenov University)","institution_ids":["https://openalex.org/I17877952"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015374870","display_name":"\u0425\u0430\u043c\u0438\u0442\u043e\u0432 \u0420\u0430\u0432\u0438\u043b\u044c \u0410\u0432\u0433\u0430\u0442\u043e\u0432\u0438\u0447","orcid":"https://orcid.org/0000-0002-1314-894X","observed_orcids":["https://orcid.org/0000-0002-1314-894X"]},"institutions":[{"id":"https://openalex.org/I4405272539","display_name":"Generium Pharmaceuticals (Russia)","ror":"https://ror.org/04anvdv29","country_code":"RU","type":"company","lineage":["https://openalex.org/I4405272539"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Ravil A. Khamitov","raw_affiliation_strings":["GENERIUM JSC"],"raw_orcid":"https://orcid.org/0000-0002-1314-894X","affiliations":[{"raw_affiliation_string":"GENERIUM JSC","institution_ids":["https://openalex.org/I4405272539"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5047632675","display_name":"Rahim R. Shukurov","orcid":"https://orcid.org/0000-0002-6532-7835","observed_orcids":["https://orcid.org/0000-0002-6532-7835"]},"institutions":[{"id":"https://openalex.org/I4405272539","display_name":"Generium Pharmaceuticals (Russia)","ror":"https://ror.org/04anvdv29","country_code":"RU","type":"company","lineage":["https://openalex.org/I4405272539"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Rahim R. Shukurov","raw_affiliation_strings":["GENERIUM JSC"],"raw_orcid":"https://orcid.org/0000-0002-6532-7835","affiliations":[{"raw_affiliation_string":"GENERIUM JSC","institution_ids":["https://openalex.org/I4405272539"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5060029889","display_name":"Ivan V. Lyagoskin","orcid":"https://orcid.org/0000-0002-9058-1106","observed_orcids":["https://orcid.org/0000-0002-9058-1106"]},"institutions":[{"id":"https://openalex.org/I4405272539","display_name":"Generium Pharmaceuticals (Russia)","ror":"https://ror.org/04anvdv29","country_code":"RU","type":"company","lineage":["https://openalex.org/I4405272539"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Ivan S. Lyagoskin","raw_affiliation_strings":["GENERIUM JSC"],"raw_orcid":"https://orcid.org/0000-0002-9058-1106","affiliations":[{"raw_affiliation_string":"GENERIUM JSC","institution_ids":["https://openalex.org/I4405272539"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5035417997","display_name":"\u041e. \u0410. Markova","orcid":"https://orcid.org/0000-0002-1179-3881","observed_orcids":["https://orcid.org/0000-0002-1179-3881"]},"institutions":[{"id":"https://openalex.org/I4405272539","display_name":"Generium Pharmaceuticals (Russia)","ror":"https://ror.org/04anvdv29","country_code":"RU","type":"company","lineage":["https://openalex.org/I4405272539"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Oksana A. Markova","raw_affiliation_strings":["GENERIUM JSC"],"raw_orcid":"https://orcid.org/0000-0002-1179-3881","affiliations":[{"raw_affiliation_string":"GENERIUM JSC","institution_ids":["https://openalex.org/I4405272539"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5069705379","display_name":"A.Yu. Borozinets","orcid":"https://orcid.org/0000-0002-4863-8471","observed_orcids":["https://orcid.org/0000-0002-4863-8471"]},"institutions":[{"id":"https://openalex.org/I4405272539","display_name":"Generium Pharmaceuticals (Russia)","ror":"https://ror.org/04anvdv29","country_code":"RU","type":"company","lineage":["https://openalex.org/I4405272539"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"Anton Yu. Borozinets","raw_affiliation_strings":["GENERIUM JSC"],"raw_orcid":"https://orcid.org/0000-0002-4863-8471","affiliations":[{"raw_affiliation_string":"GENERIUM JSC","institution_ids":["https://openalex.org/I4405272539"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":8.6907,"has_fulltext":true,"cited_by_count":2,"citation_normalized_percentile":{"value":0.95903753,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":95,"max":96},"biblio":{"volume":"97","issue":"12","first_page":"1009","last_page":"1017"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10945","display_name":"Lysosomal Storage Disorders Research","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2716","display_name":"Genetics (clinical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10945","display_name":"Lysosomal Storage Disorders Research","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2716","display_name":"Genetics (clinical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11280","display_name":"Hemophilia Treatment and Research","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/hunter-syndrome","display_name":"Hunter syndrome","score":0.9539999961853027},{"id":"https://openalex.org/keywords/iduronate-2-sulfatase","display_name":"iduronate-2-sulfatase","score":0.9200000166893005},{"id":"https://openalex.org/keywords/enzyme-replacement-therapy","display_name":"enzyme replacement therapy","score":0.8690000176429749},{"id":"https://openalex.org/keywords/blood-brain-barrier","display_name":"blood-brain barrier","score":0.6209999918937683},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.6710000038146973},{"id":"https://openalex.org/keywords/safety-and-tolerability","display_name":"safety and tolerability","score":0.9190000295639038},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.7390000224113464},{"id":"https://openalex.org/keywords/dose-escalation","display_name":"dose escalation","score":0.6370000243186951},{"id":"https://openalex.org/keywords/nonlinear-pharmacokinetics","display_name":"nonlinear pharmacokinetics","score":0.8040000200271606},{"id":"https://openalex.org/keywords/monoclonal-antibody-fab-fragment","display_name":"monoclonal antibody Fab fragment","score":0.6209999918937683},{"id":"https://openalex.org/keywords/elevated-bilirubin","display_name":"bilirubin elevation","score":0.6470000147819519},{"id":"https://openalex.org/keywords/drug-clearance","display_name":"drug clearance","score":0.4000000059604645},{"id":"https://openalex.org/keywords/half-life","display_name":"half-life","score":0.6340000033378601}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9344000220298767},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.9154999852180481},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.8065000176429749},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.6870999932289124},{"id":"https://openalex.org/C139254425","wikidata":"https://www.wikidata.org/wiki/Q1332167","display_name":"Volume of distribution","level":3,"score":0.5867000222206116},{"id":"https://openalex.org/C110121322","wikidata":"https://www.wikidata.org/wiki/Q865811","display_name":"Distribution (mathematics)","level":2,"score":0.3939000070095062},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.3531000018119812},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.33059999346733093},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.3303999900817871},{"id":"https://openalex.org/C2909957684","wikidata":"https://www.wikidata.org/wiki/Q1163287","display_name":"Metabolic clearance rate","level":3,"score":0.3206000030040741},{"id":"https://openalex.org/C2908944559","wikidata":"https://www.wikidata.org/wiki/Q1332167","display_name":"Distribution Volume","level":4,"score":0.3131999969482422},{"id":"https://openalex.org/C3018359032","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Safety profile","level":3,"score":0.27000001072883606},{"id":"https://openalex.org/C3019775314","wikidata":"https://www.wikidata.org/wiki/Q1781748","display_name":"Tissue distribution","level":2,"score":0.26489999890327454},{"id":"https://openalex.org/C111113717","wikidata":"https://www.wikidata.org/wiki/Q725307","display_name":"Pharmacodynamics","level":3,"score":0.2581000030040741}],"mesh":[{"descriptor_ui":"D000293","descriptor_name":"Adolescent","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004305","descriptor_name":"Dose-Response Relationship, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007066","descriptor_name":"Iduronate Sulfatase","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D007066","descriptor_name":"Iduronate Sulfatase","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D007066","descriptor_name":"Iduronate Sulfatase","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011993","descriptor_name":"Recombinant Fusion Proteins","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D011993","descriptor_name":"Recombinant Fusion Proteins","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D011993","descriptor_name":"Recombinant Fusion Proteins","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D016532","descriptor_name":"Mucopolysaccharidosis II","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D056947","descriptor_name":"Enzyme Replacement Therapy","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D064368","descriptor_name":"Healthy Volunteers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.26442/00403660.2025.12.203550","doi":"https://doi.org/10.26442/00403660.2025.12.203550","is_oa":true,"landing_page_url":"https://doi.org/10.26442/00403660.2025.12.203550","pdf_url":"https://ter-arkhiv.ru/0040-3660/article/download/696567/219049","source":{"id":"https://openalex.org/S27897580","display_name":"Terapevticheskii arkhiv","issn_l":"0040-3660","issn":["0040-3660","2309-5342"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jufo-1","medline","norway-1","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4320800547","host_organization_name":"Consilium Medicum","host_organization_lineage":["https://openalex.org/P4320800547"],"host_organization_lineage_names":["Consilium Medicum"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Terapevticheskii arkhiv","raw_type":"journal-article"},{"id":"pmid:41705613","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41705613","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Terapevticheskii arkhiv","raw_type":"Clinical Trial, Phase I"},{"id":"pmh:oai:doaj.org/article:8707975c0534411e857514ba60737923","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/8707975c0534411e857514ba60737923","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"\u0422\u0435\u0440\u0430\u043f\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0439 \u0430\u0440\u0445\u0438\u0432, Vol 97, Iss 12, Pp 1009-1017 (2025)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.26442/00403660.2025.12.203550","doi":"https://doi.org/10.26442/00403660.2025.12.203550","is_oa":true,"landing_page_url":"https://doi.org/10.26442/00403660.2025.12.203550","pdf_url":"https://ter-arkhiv.ru/0040-3660/article/download/696567/219049","source":{"id":"https://openalex.org/S27897580","display_name":"Terapevticheskii arkhiv","issn_l":"0040-3660","issn":["0040-3660","2309-5342"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jufo-1","medline","norway-1","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4320800547","host_organization_name":"Consilium Medicum","host_organization_lineage":["https://openalex.org/P4320800547"],"host_organization_lineage_names":["Consilium Medicum"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Terapevticheskii arkhiv","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7128906142.pdf","grobid_xml":"https://content.openalex.org/works/W7128906142.grobid-xml"},"referenced_works_count":24,"referenced_works":["https://openalex.org/W1986852088","https://openalex.org/W2093722439","https://openalex.org/W2112358239","https://openalex.org/W2762583518","https://openalex.org/W2830135676","https://openalex.org/W2904356201","https://openalex.org/W2999466514","https://openalex.org/W3006540808","https://openalex.org/W3090225575","https://openalex.org/W3207049837","https://openalex.org/W4200610496","https://openalex.org/W4214625899","https://openalex.org/W4285733033","https://openalex.org/W4289525295","https://openalex.org/W4295866773","https://openalex.org/W4362522157","https://openalex.org/W4378217890","https://openalex.org/W4386559443","https://openalex.org/W4392714205","https://openalex.org/W4402819439","https://openalex.org/W4403217503","https://openalex.org/W4403296727","https://openalex.org/W4410556384","https://openalex.org/W4415827866"],"related_works":["https://openalex.org/W7162943195","https://openalex.org/W7140090694","https://openalex.org/W7127394401","https://openalex.org/W2789408646","https://openalex.org/W7117322930","https://openalex.org/W2830135676","https://openalex.org/W4408531578","https://openalex.org/W4390743640","https://openalex.org/W7133756676","https://openalex.org/W4408531958"],"abstract_inverted_index":{"Background.":[0],"Enzyme":[1],"replacement":[2],"drugs":[3],"for":[4,47,99],"treatment":[5],"of":[6,35,49,62,69,105,129,248,288,294],"mucopolysaccharidosis":[7],"type":[8],"II":[9],"(MPS":[10],"II)":[11],"do":[12],"not":[13],"penetrate":[14],"the":[15,50,127,140,157,189,214,236,284,295],"blood-brain":[16],"barrier,":[17],"significantly":[18],"reducing":[19],"their":[20,137],"efficacy":[21],"in":[22,72,161,167,173,198,267,279],"patients":[23],"with":[24,235,275,283,292],"neuropathic":[25],"form.":[26],"Verenafusp":[27,94],"alfa":[28,64,95,250],"(Clotilia\u00ae)":[29],"is":[30],"a":[31,38,149,195,260,276],"recombinant":[32],"fusion":[33],"protein":[34],"iduronate-2-sulfatase":[36],"and":[37,59,76,118,131,136,169,176,211,232,264,281],"monoclonal":[39],"antibody":[40],"Fab":[41],"fragment":[42],"to":[43,89,139,171,188,206,220,229,241,256],"human":[44],"insulin":[45],"receptor":[46],"distribution":[48,289],"enzyme":[51],"into":[52],"brain.":[53],"Aim.":[54],"To":[55],"evaluate":[56],"safety,":[57],"tolerability,":[58],"pharmacokinetic":[60],"parameters":[61,145],"verenafusp":[63,249],"after":[65],"single":[66,103],"intravenous":[67,246],"administration":[68,247],"escalating":[70],"doses":[71,104,252],"healthy":[73,84,268],"volunteers.":[74,269],"Materials":[75],"methods.":[77],"This":[78],"open-label,":[79],"multicohort":[80],"study":[81,190],"included":[82],"20":[83,154],"male":[85],"volunteers":[86,155,164],"aged":[87],"18":[88],"47":[90],"years":[91],"(26.1\u00b17.8":[92],"years).":[93],"was":[96,123,185,273],"administered":[97],"intravenously":[98],"3":[100,119,257],"hours":[101],"at":[102,251],"0.3":[106,255],"mg/kg":[107,110,113,116,120,258],"(n=1),":[108,111],"0.5":[109],"1":[112],"(n=6),":[114,117],"2":[115],"(n=6).":[121],"Safety":[122],"assessed":[124],"based":[125],"on":[126],"incidence":[128],"clinical":[130],"laboratory":[132,175],"adverse":[133],"events":[134],"(AEs)":[135],"relationship":[138],"investigational":[141],"medicinal":[142],"product.":[143],"Pharmacokinetic":[144,192],"were":[146,165],"calculated":[147],"using":[148],"noncompartmental":[150],"method.":[151],"Results.":[152],"All":[153],"completed":[156],"study.":[158],"AEs":[159],"reported":[160],"6":[162],"(30%)":[163],"mild":[166],"severity":[168],"related":[170,187],"changes":[172],"individual":[174],"instrumental":[177],"test":[178],"data.":[179],"One":[180],"AE":[181],"(increased":[182],"bilirubin":[183],"level)":[184],"possibly":[186],"drug.":[191],"analysis":[193],"demonstrated":[194,259],"dose-dependent":[196,277],"increase":[197,278,293],"maximum":[199],"concentration":[200],"(Cmax)":[201],"from":[202,218,227,239,254],"197.60":[203],"(0.3":[204],"mg/kg)":[205,210],"10,225.80":[207],"ng/mL":[208],"(3":[209],"area":[212],"under":[213],"concentration-time":[215],"curve":[216],"(AUC)":[217],"38,678.60":[219],"2,714,067.42":[221],"ng\u00d7min/mL":[222],"respectively.":[223],"The":[224,270],"half-life":[225],"ranged":[226],"86.69":[228],"213.42":[230],"minutes,":[231],"clearance":[233],"lowered":[234,291],"increasing":[237],"dose":[238,285],"7.67":[240],"1.11":[242],"mL/min/kg.":[243],"Conclusion.":[244],"Single":[245],"ranging":[253],"favorable":[261],"safety":[262],"profile":[263],"good":[265],"tolerability":[266],"drug's":[271],"pharmacokinetics":[272],"nonlinear,":[274],"Cmax":[280],"AUC":[282],"increment.":[286],"Volume":[287],"volume":[290],"dose.":[296]},"counts_by_year":[{"year":2026,"cited_by_count":2}],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2026-02-15T00:00:00"}