protocolSection identificationModule nctId: NCT06310551, orgStudyIdInfo id: 218804, briefTitle: First Time in Human Study of Long Acting VH4524184 Formulations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-02-13, completionDateStruct date: 2026-11-27, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ViiV Healthcare, class: INDUSTRY, collaborators name: GlaxoSmithKline, descriptionModule 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., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Oral VH4524184, interventions name: VH4524184 Formulation A SC, interventions name: Placebo Formulation A SC, interventions name: rHuPH20, interventions name: VH4524184 Formulation B SC, interventions name: Placebo Formulation B SC, interventions name: VH4524184 Formulation C SC, interventions name: Placebo Formulation C SC, interventions name: VH4524184 Formulation A IM, interventions name: Placebo Formulation A IM, outcomesModule primaryOutcomes measure: Percentage of participants reporting AEs and related AEs, primaryOutcomes measure: Percentage of participants with AEs by severity, primaryOutcomes measure: Percentage of participants discontinuing the treatment due to AEs, primaryOutcomes measure: Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase), primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin), primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio), primaryOutcomes measure: Percentage of participants reporting injection site reaction (ISR) AEs, primaryOutcomes measure: Duration of injection site reaction AEs, primaryOutcomes 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, primaryOutcomes 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, primaryOutcomes measure: Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration, primaryOutcomes measure: Cmax of LAI VH4524184 following multiple dose administration, primaryOutcomes measure: Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration, primaryOutcomes measure: Tmax of LAI VH4524184 following multiple dose administration, primaryOutcomes measure: Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration, primaryOutcomes measure: t1/2 of LAI VH4524184 following multiple dose administration, secondaryOutcomes measure: Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Patrick Yao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95362, lon: -94.73357, locations facility: GSK Investigational Site, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Chinonye Chika Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False