First Time in Human Study of Long Acting VH4524184 Formulations

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

January 21, 2028

Study Completion Date

January 21, 2028

Conditions
HIV Infections
Interventions
DRUG

Oral VH4524184

VH4524184 to be taken orally.

DRUG

VH4524184 Formulation A SC

Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.

DRUG

Placebo Formulation A SC

Starting dose of Placebo Formulation A administered subcutaneously.

DRUG

rHuPH20

Dose of rHuPH20 administered subcutaneously.

DRUG

VH4524184 Formulation B SC

Starting dose of VH4524184 LAI Formulation B administered subcutaneously.

DRUG

Placebo Formulation B SC

Starting dose of Placebo Formulation B administered subcutaneously.

DRUG

VH4524184 Formulation C SC

Starting dose of VH4524184 LAI Formulation C administered subcutaneously.

DRUG

Placebo Formulation C SC

Dose of Placebo Formulation C administered subcutaneously.

DRUG

VH4524184 Formulation A IM

Starting dose VH4524184 LAI Formulation A administered intramuscularly.

DRUG

Placebo Formulation A IM

Dose of Placebo Formulation A administered intramuscularly.

DRUG

VH4524184 Formulation B IM

Starting dose VH4524184 LAI Formulation B administered intramuscularly.

DRUG

Placebo Formulation B IM

Dose of Placebo Formulation B administered intramuscularly.

Trial Locations (2)

66219

RECRUITING

GSK Investigational Site, Lenexa

78209

RECRUITING

GSK Investigational Site, San Antonio

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY