nctId: NCT06310551 id: 218804 briefTitle: First Time in Human Study of Long Acting VH4524184 Formulations overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2025-02-13 date: 2026-11-27 date: 2024-03-15 date: 2024-03-15 name: ViiV Healthcare class: INDUSTRY name: GlaxoSmithKline briefSummary: The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection. conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: Oral VH4524184 name: VH4524184 Formulation A SC name: Placebo Formulation A SC name: rHuPH20 name: VH4524184 Formulation B SC name: Placebo Formulation B SC name: VH4524184 Formulation C SC name: Placebo Formulation C SC name: VH4524184 Formulation A IM name: Placebo Formulation A IM measure: Percentage of participants reporting AEs and related AEs measure: Percentage of participants with AEs by severity measure: Percentage of participants discontinuing the treatment due to AEs measure: Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184 measure: Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184 measure: Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184 measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase) measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin) measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio) measure: Percentage of participants reporting injection site reaction (ISR) AEs measure: Duration of injection site reaction AEs measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration measure: Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration measure: Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration measure: Cmax of LAI VH4524184 following multiple dose administration measure: Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration measure: Tmax of LAI VH4524184 following multiple dose administration measure: Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration measure: t1/2 of LAI VH4524184 following multiple dose administration measure: Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: GSK Investigational Site city: Lenexa state: Kansas zip: 66219 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Patrick Yao role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 facility: GSK Investigational Site city: San Antonio state: Texas zip: 78209 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Chinonye Chika Ogbonnaya-Odor role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False