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First Time in Human Study of Long Acting VH4524184 Formulations

NCT06310551 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-04-20

No results posted yet for this study

Summary

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

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 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.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2028-01-21
Completion
2028-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310551 on ClinicalTrials.gov