First Time in Human Study of Long Acting VH4524184 Formulations

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Oral VH4524184 — DRUG
  VH4524184 to be taken orally.
• VH4524184 Formulation A SC — DRUG
  Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.
• Placebo Formulation A SC — DRUG
  Starting dose of Placebo Formulation A administered subcutaneously.
• rHuPH20 — DRUG
  Dose of rHuPH20 administered subcutaneously.
• VH4524184 Formulation B SC — DRUG
  Starting dose of VH4524184 LAI Formulation B administered subcutaneously.
• Placebo Formulation B SC — DRUG
  Starting dose of Placebo Formulation B administered subcutaneously.
• VH4524184 Formulation A IM — DRUG
  Starting dose VH4524184 LAI Formulation A administered intramuscularly.
• Placebo Formulation A IM — DRUG
  Dose of Placebo Formulation A administered intramuscularly.
• VH4524184 Formulation B IM — DRUG
  Starting dose VH4524184 LAI Formulation B administered intramuscularly.
• Placebo Formulation B IM — DRUG
  Dose of Placebo Formulation B administered intramuscularly.

Study Details

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.

Key Dates

Start date

Mar 21, 2024

Status verified

Apr 2026

Primary completion

Jan 21, 2028

Completion

Jan 21, 2028

Study Design

Enrollment

268 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Formulation A SC Group
  Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).
• Experimental: Formulation B SC Group
  Participants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC).
• Experimental: Formulation A IM Group
  Participants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM).
• Experimental: Formulation B IM Group
  Participants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM).
• Experimental: Multiple doses Group
  VH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses.

Primary Outcome Measure

Percentage of participants reporting adverse events (AEs) and related AEs [ Time Frame: From first study dose administration (Day 1) up to study end (Week 52 post last dose) ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (3)

Find similar trials in Lenexa, KS

Related Studies

• A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
  PHASE1 · Recruiting · ViiV Healthcare · Orlando, Florida
• Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
  PHASE2 · Recruiting · Priscilla Hsue, MD · Los Angeles, California
• Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
  PHASE1/PHASE2 · Recruiting · ViiV Healthcare · Long Beach, California
• Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
  Recruiting · Children's Hospital Medical Center, Cincinnati · Columbus, Ohio