biostudies-literatureEdupuganti SNational Institute of Allergy and Infectious Diseases Division of Intramural ResearchNIAID NIH HHSe13-e25https://www.ebi.ac.uk/biostudies/studies/S-EPMC11795396biostudies-literatureUnknown12(1)<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 The lancet. HIVSafety, 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.PMC11795396P30 AI050410UM1 AI069412UM1 AI069424UM1 AI068635UM1 AI068613U01 AI069470UM1 AI154466UM1 AI068614UM1 AI068617UM1 AI068619UM1 AI068618UM1 AI069470P30 AI064518Babinec APaz AAPaez CASiegel MKarg CGonzalez MZhang LGama LLintner MPierce NHurt CBLucas JWalsh SRGildea MCurate-Ingram SBeck JWeiner JAMark LRinn LCummings VSaintilma BGrossman JSobieszczyk MHe ZYellin HAckerley CGPiermattei AChaturvedi RRandhawa AHeptinstall JBaral SHVTN 136/HPTN 092 Study TeamWhite HKuo MHan XWagh KPiwowar-Manning EHasan SMiner MDKuo IPowell MRegenold SBaden LHeithoff ASpiegel HKelley CChege WSherman AYen CPensiero MHuang YYu CBalachandran MChiong KTomaras GDHanke JGraciaa DBaumblatt JYates NAckerman MEFair RCooley WSRouphael NMagnus MAxelrod KSNagar SHunt MKhodabakhshian AKorber BDumond JSeaton KEChicurel-Bayard MFortier SGamble TSane NDoria-Rose NLandovitz RJMayer KDarden-Tabb NJordan JAfemata SEdupuganti SKlopfer JMontefiori DCLanglands KMcKee KCoomes BKovacikova GRobinson MHanscom BBarouch DHDonaty KDomin EMcClosky NAnderson MGothing JTindale IBroder GDye BJLin BCStephenson KEfalseSafety, 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.<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 2025-01-01T00:00:00Z2025 Jan2026-06-06T17:26:20.665Z2026-06-03T03:10:30.205ZS-EPMC117953963966737910.1016/S2352-3018(24)00247-910.1016/s2352-3018(24)00247-9