{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Edupuganti S"],"funding":["National Institute of Allergy and Infectious Diseases Division of Intramural Research","NIAID NIH HHS"],"pagination":["e13-e25"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11795396"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["12(1)"],"pubmed_abstract":["<h4>Background</h4>Multiple broadly neutralising monoclonal antibodies (mAbs) are in development for HIV-1 prevention. The aim of this trial was to test the PGT121.414.LS and VRC07-523LS mAbs for safety and pharmacokinetics in adults.<h4>Methods</h4>In this first-in-human phase 1 trial (HVTN 136/HPTN 092), adults without HIV were enrolled at six university-affiliated clinical research sites in the USA. Part A evaluated escalating single intravenous doses or subcutaneous infusion of PGT121.414.LS, in four groups: 3 mg/kg intravenous (treatment group 1; n=3), 10 mg/kg intravenous (treatment group 2; n=4), 30 mg/kg intravenous (treatment group 3; n=3), and 5 mg/kg subcutaneous (treatment group 4; n=3). Part B evaluated repeated sequential intravenous administrations of 20 mg/kg PGT121.414.LS "],"journal":["The lancet. HIV"],"pubmed_title":["Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial."],"pmcid":["PMC11795396"],"funding_grant_id":["P30 AI050410","UM1 AI069412","UM1 AI069424","UM1 AI068635","UM1 AI068613","U01 AI069470","UM1 AI154466","UM1 AI068614","UM1 AI068617","UM1 AI068619","UM1 AI068618","UM1 AI069470","P30 AI064518"],"pubmed_authors":["Babinec A","Paz AA","Paez CA","Siegel M","Karg C","Gonzalez M","Zhang L","Gama L","Lintner M","Pierce N","Hurt CB","Lucas J","Walsh SR","Gildea M","Curate-Ingram S","Beck J","Weiner JA","Mark L","Rinn L","Cummings V","Saintilma B","Grossman J","Sobieszczyk M","He Z","Yellin H","Ackerley CG","Piermattei A","Chaturvedi R","Randhawa A","Heptinstall J","Baral S","HVTN 136/HPTN 092 Study Team","White H","Kuo M","Han X","Wagh K","Piwowar-Manning E","Hasan S","Miner MD","Kuo I","Powell M","Regenold S","Baden L","Heithoff A","Spiegel H","Kelley C","Chege W","Sherman A","Yen C","Pensiero M","Huang Y","Yu C","Balachandran M","Chiong K","Tomaras GD","Hanke J","Graciaa D","Baumblatt J","Yates N","Ackerman ME","Fair R","Cooley WS","Rouphael N","Magnus M","Axelrod KS","Nagar S","Hunt M","Khodabakhshian A","Korber B","Dumond J","Seaton KE","Chicurel-Bayard M","Fortier S","Gamble T","Sane N","Doria-Rose N","Landovitz RJ","Mayer K","Darden-Tabb N","Jordan J","Afemata S","Edupuganti S","Klopfer J","Montefiori DC","Langlands K","McKee K","Coomes B","Kovacikova G","Robinson M","Hanscom B","Barouch DH","Donaty K","Domin E","McClosky N","Anderson M","Gothing J","Tindale I","Broder G","Dye BJ","Lin BC","Stephenson KE"],"additional_accession":[]},"is_claimable":false,"name":"Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial.","description":"<h4>Background</h4>Multiple broadly neutralising monoclonal antibodies (mAbs) are in development for HIV-1 prevention. The aim of this trial was to test the PGT121.414.LS and VRC07-523LS mAbs for safety and pharmacokinetics in adults.<h4>Methods</h4>In this first-in-human phase 1 trial (HVTN 136/HPTN 092), adults without HIV were enrolled at six university-affiliated clinical research sites in the USA. Part A evaluated escalating single intravenous doses or subcutaneous infusion of PGT121.414.LS, in four groups: 3 mg/kg intravenous (treatment group 1; n=3), 10 mg/kg intravenous (treatment group 2; n=4), 30 mg/kg intravenous (treatment group 3; n=3), and 5 mg/kg subcutaneous (treatment group 4; n=3). Part B evaluated repeated sequential intravenous administrations of 20 mg/kg PGT121.414.LS ","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jan","modification":"2026-06-06T17:26:20.665Z","creation":"2026-06-03T03:10:30.205Z"},"accession":"S-EPMC11795396","cross_references":{"pubmed":["39667379"],"doi":["10.1016/S2352-3018(24)00247-9","10.1016/s2352-3018(24)00247-9"]}}