{"id":"https://openalex.org/W4200317976","doi":"https://doi.org/10.1093/ofid/ofab466.1293","title":"1099. Evaluation of the Safety and Pharmacokinetics (PK) following Administration of Single and Multiple Doses of Anti-Staphylococcal Lysin, LSVT-1701, in Healthy Adult Subjects","display_name":"1099. Evaluation of the Safety and Pharmacokinetics (PK) following Administration of Single and Multiple Doses of Anti-Staphylococcal Lysin, LSVT-1701, in Healthy Adult Subjects","publication_year":2021,"publication_date":"2021-11-01","ids":{"openalex":"https://openalex.org/W4200317976","doi":"https://doi.org/10.1093/ofid/ofab466.1293"},"language":"en","primary_location":{"id":"doi:10.1093/ofid/ofab466.1293","doi":"https://doi.org/10.1093/ofid/ofab466.1293","is_oa":true,"landing_page_url":"https://doi.org/10.1093/ofid/ofab466.1293","pdf_url":null,"source":{"id":"https://openalex.org/S2735126445","display_name":"Open Forum Infectious Diseases","issn_l":"2328-8957","issn":["2328-8957"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Open Forum Infectious Diseases","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1093/ofid/ofab466.1293","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5091022464","display_name":"Mary Beth Wire","orcid":"https://orcid.org/0000-0001-8938-7288","observed_orcids":["https://orcid.org/0000-0001-8938-7288"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Mary Beth Wire","raw_affiliation_strings":["Lysovant, New York, New York"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lysovant, New York, New York","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015438596","display_name":"Soo Youn Jun","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210121401","display_name":"iNtRON (South Korea)","ror":"https://ror.org/01xdejb38","country_code":"KR","type":"company","lineage":["https://openalex.org/I4210121401"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Soo youn Jun","raw_affiliation_strings":["iNtRON Biotechnology, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"iNtRON Biotechnology, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea","institution_ids":["https://openalex.org/I4210121401"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5003039593","display_name":"In-Jin Jany","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210121401","display_name":"iNtRON (South Korea)","ror":"https://ror.org/01xdejb38","country_code":"KR","type":"company","lineage":["https://openalex.org/I4210121401"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"In-Jin Jany","raw_affiliation_strings":["iNtRON, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"iNtRON, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea","institution_ids":["https://openalex.org/I4210121401"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072366268","display_name":"Jun Gi Hwang","orcid":"https://orcid.org/0000-0002-0965-0531","observed_orcids":["https://orcid.org/0000-0002-0965-0531"]},"institutions":[{"id":"https://openalex.org/I4210121401","display_name":"iNtRON (South Korea)","ror":"https://ror.org/01xdejb38","country_code":"KR","type":"company","lineage":["https://openalex.org/I4210121401"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Jun Gi Hwang","raw_affiliation_strings":["iNtRON Biotechnology, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"iNtRON Biotechnology, Seoul, Seoul-t\u2019ukpyolsi, Republic of Korea","institution_ids":["https://openalex.org/I4210121401"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5016570350","display_name":"David B. Huang","orcid":"https://orcid.org/0000-0001-8228-7911","observed_orcids":["https://orcid.org/0000-0001-8228-7911","https://orcid.org/0000-0002-8342-3193"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"David Huang","raw_affiliation_strings":["Lysovant, New York, New York"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lysovant, New York, New York","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":3465,"currency":"USD","value_usd":3465},"apc_paid":{"value":3465,"currency":"USD","value_usd":3465},"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"8","issue":"Supplement_1","first_page":"S641","last_page":"S641"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11048","display_name":"Bacteriophages and microbial interactions","score":0.7378000020980835,"subfield":{"id":"https://openalex.org/subfields/2303","display_name":"Ecology"},"field":{"id":"https://openalex.org/fields/23","display_name":"Environmental Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11048","display_name":"Bacteriophages and microbial interactions","score":0.7378000020980835,"subfield":{"id":"https://openalex.org/subfields/2303","display_name":"Ecology"},"field":{"id":"https://openalex.org/fields/23","display_name":"Environmental Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10195","display_name":"Antimicrobial Resistance in Staphylococcus","score":0.2304999977350235,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"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/T11036","display_name":"Antibiotics Pharmacokinetics and Efficacy","score":0.005499999970197678,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology"},"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/methicillin-resistant-staphylococcus-aureus","display_name":"methicillin-resistant Staphylococcus aureus","score":0.5249999761581421},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.8679999709129333},{"id":"https://openalex.org/keywords/multiple-ascending-dose","display_name":"multiple ascending dose","score":0.8980000019073486},{"id":"https://openalex.org/keywords/safety","display_name":"safety","score":0.6110000014305115},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.5519999861717224},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.5080000162124634},{"id":"https://openalex.org/keywords/drug-drug-interactions","display_name":"drug-drug interactions","score":0.4000000059604645},{"id":"https://openalex.org/keywords/drug-disease-interactions","display_name":"drug-disease interactions","score":0.41200000047683716},{"id":"https://openalex.org/keywords/combination-antibiotic-therapy","display_name":"combination antibiotic therapy","score":0.40799999237060547},{"id":"https://openalex.org/keywords/phage-therapy","display_name":"phage therapy","score":0.41999998688697815},{"id":"https://openalex.org/keywords/staphylococcus-aureus","display_name":"Staphylococcus aureus","score":0.6029999852180481},{"id":"https://openalex.org/keywords/intravenous-administration","display_name":"intravenous administration","score":0.36399999260902405},{"id":"https://openalex.org/keywords/dose-limiting-toxicity","display_name":"dose-limiting toxicity","score":0.41999998688697815}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9182593822479248},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.6848772764205933},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.4276670217514038},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3326416313648224},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1093/ofid/ofab466.1293","doi":"https://doi.org/10.1093/ofid/ofab466.1293","is_oa":true,"landing_page_url":"https://doi.org/10.1093/ofid/ofab466.1293","pdf_url":null,"source":{"id":"https://openalex.org/S2735126445","display_name":"Open Forum Infectious Diseases","issn_l":"2328-8957","issn":["2328-8957"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Open Forum Infectious Diseases","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:8644714","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/8644714","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Open Forum Infect Dis","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1093/ofid/ofab466.1293","doi":"https://doi.org/10.1093/ofid/ofab466.1293","is_oa":true,"landing_page_url":"https://doi.org/10.1093/ofid/ofab466.1293","pdf_url":null,"source":{"id":"https://openalex.org/S2735126445","display_name":"Open Forum Infectious Diseases","issn_l":"2328-8957","issn":["2328-8957"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Open Forum Infectious Diseases","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":1.0,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4206182690","https://openalex.org/W4200555624","https://openalex.org/W4389085105","https://openalex.org/W2601574108","https://openalex.org/W4386324590","https://openalex.org/W2905372020","https://openalex.org/W2943626940","https://openalex.org/W4402311793","https://openalex.org/W4247060083","https://openalex.org/W2049335064"],"abstract_inverted_index":{"Abstract":[0],"Background":[1],"LSVT-1701":[2,29,57,86,143,153,214,299,319,325,330,340],"is":[3,341],"an":[4],"anti-staphylococcal":[5],"phage":[6],"lysin":[7],"being":[8],"developed":[9],"for":[10,106,140,245,343,356],"treatment":[11],"of":[12,24,28,52,56,100,142,152,199,223,237,287,324,329,339],"MRSA":[13],"infections":[14],"in":[15,34,58,83,212,258,271,304,318,345],"combination":[16],"with":[17,248,284,291,313,347],"SoC":[18],"antibiotics.":[19],"The":[20,233,334],"safety":[21,49,335],"and":[22,50,95,103,137,170,185,194,206,220,241,253,308,336,353],"PK":[23,51,150,326,331,337],"single":[25,93,217,293],"ascending":[26,54,73],"doses":[27,55,99,139],"0.1":[30],"to":[31,81,183,202,227,306],"10":[32],"mg/kg":[33,92,105,216,229,295],"healthy":[35,59],"adult":[36,60],"volunteers":[37],"were":[38,78,119,129,187,198,207,273,282],"previously":[39],"described":[40],"(Jun,":[41],"et.al,":[42],"AAC":[43],"2017;61:e02629-16).":[44],"We":[45],"further":[46],"evaluated":[47],"the":[48,135,177,213,292],"multiple":[53,72],"subjects.":[61],"Methods":[62],"Study":[63,117],"ITB-101-1b":[64],"was":[65,87,156,162,310,321],"a":[66,90,122,146],"Phase":[67],"1,":[68],"randomized,":[69],"double-blind,":[70],"placebo-controlled,":[71],"dose":[74,94,218,296,307],"study.":[75,178],"8":[76],"subjects":[77,175,180,211,224],"randomized":[79],"3:1":[80],"active:placebo":[82],"each":[84],"cohort.":[85],"administered":[88,120],"as":[89,121],"6":[91,215,294],"twice":[96],"daily":[97],"(BID)":[98],"1.5,":[101],"3.0,":[102],"4.5":[104,228],"4":[107],"days":[108,247],"(24h":[109],"between":[110,114],"Doses":[111,115],"1-2,":[112],"12h":[113],"2-6).":[116],"drugs":[118],"1-hour":[123],"IV":[124],"infusion.":[125],"Serial":[126],"serum":[127],"samples":[128],"collected":[130],"over":[131],"24":[132],"hours":[133],"following":[134],"first":[136],"last":[138],"measurement":[141],"concentrations":[144],"by":[145,164,209],"validated":[147],"ELISA":[148],"method.":[149],"analysis":[151],"concentration-time":[154],"data":[155],"done":[157],"using":[158],"noncompartmental":[159],"methods.":[160],"Safety":[161],"assessed":[163],"AEs,":[165,184,190,193],"clinical":[166,265],"labs,":[167],"vital":[168],"signs,":[169],"ECG.":[171],"Results":[172],"30/32":[173],"(94%)":[174],"completed":[176],"No":[179,316],"withdrew":[181],"due":[182],"there":[186],"no":[188,191,195,254],"severe":[189],"serious":[192],"deaths.":[196],"AEs":[197,236],"mild":[200],"(97%)":[201],"moderate":[203],"(3%)":[204],"intensity":[205],"reported":[208],"all":[210],"group":[219],"1-3":[221],"(17-50%)":[222],"receiving":[225],"1.5":[226],"BID":[230,285],"or":[231,249,264,297],"placebo.":[232,298],"most":[234],"common":[235],"headache,":[238],"chills,":[239],"rigors,":[240],"fever":[242],"generally":[243],"lasted":[244],"\u22642":[246],"without":[250],"acetaminophen":[251],"treatment,":[252],"clinically":[255],"significant":[256],"changes":[257],"blood":[259],"pressure,":[260],"heart":[261],"rate,":[262],"ECG,":[263],"labs":[266],"(other":[267],"than":[268,303],"transient":[269],"increases":[270],"CRP)":[272],"observed.":[274,322],"Infusion":[275],"site":[276],"reactions":[277],"(erythema,":[278],"pain,":[279],"induration,":[280],"warmth)":[281],"observed":[283],"administration":[286],"LSVT-1701,":[288],"but":[289],"not":[290],"exposure":[300,320],"increased":[301],"greater":[302],"proportion":[305],"t1/2":[309],"concentration-dependent,":[311],"increasing":[312],"higher":[314],"doses.":[315],"accumulation":[317],"Summary":[323,328],"Parameters":[327,332],"Conclusion":[333],"profile":[338],"favorable":[342],"evaluation":[344],"patients":[346],"S.":[348],"aureus":[349],"infections,":[350],"including":[351],"bacteremia":[352],"infective":[354],"endocarditis,":[355],"which":[357],"new":[358],"treatments":[359],"are":[360],"needed.":[361],"Disclosures":[362],"Mary":[363],"Beth":[364],"Wire,":[365],"Pharm#,":[366],"Lysovant":[367,385,391],"(Consultant)":[368,375,380,386,392],"Soo":[369],"youn":[370],"Jun,":[371],"PhD,":[372,378,384,390],"iNtRON":[373,379],"Biotechnology":[374],"In-Jin":[376],"Jany,":[377],"Jun":[381],"Gi":[382],"Hwang,":[383],"David":[387],"Huang,":[388],"MD,":[389]},"counts_by_year":[],"updated_date":"2026-10-27T15:51:10.671819","created_date":"2021-12-31T00:00:00"}
