RecruitingPhase 1NCT06310551

First Time in Human Study of Long Acting VH4524184 Formulations

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults


Sponsor

ViiV Healthcare

Enrollment

268 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing different formulations (injection types) of a new long-acting drug called VH4524184 in healthy volunteers. The study aims to find a safe dose and determine how long the drug stays in the body. **You may be eligible if...** - You are between 18 and 55 years old - You are in good overall health with no significant medical conditions - You test negative for COVID-19 (SARS-CoV-2) on admission - Your weight and BMI fall within the acceptable study ranges - You are not pregnant and willing to use appropriate contraception if applicable **You may NOT be eligible if...** - You have significant medical conditions (heart, liver, kidney, or other organ problems) - You have a history of drug or alcohol abuse - You are pregnant or breastfeeding - You have used recreational drugs recently or tested positive for drugs at screening - You have taken other investigational (experimental) drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral VH4524184

VH4524184 to be taken orally.

DRUGVH4524184 Formulation A SC

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

DRUGPlacebo Formulation A SC

Starting dose of Placebo Formulation A administered subcutaneously.

DRUGrHuPH20

Dose of rHuPH20 administered subcutaneously.

DRUGVH4524184 Formulation B SC

Starting dose of VH4524184 LAI Formulation B administered subcutaneously.

DRUGPlacebo Formulation B SC

Starting dose of Placebo Formulation B administered subcutaneously.

DRUGVH4524184 Formulation A IM

Starting dose VH4524184 LAI Formulation A administered intramuscularly.

DRUGPlacebo Formulation A IM

Dose of Placebo Formulation A administered intramuscularly.

DRUGVH4524184 Formulation B IM

Starting dose VH4524184 LAI Formulation B administered intramuscularly.

DRUGPlacebo Formulation B IM

Dose of Placebo Formulation B administered intramuscularly.


Locations(3)

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06310551


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