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RecruitingPhase 1NCT06724640

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV

Sponsor

ViiV Healthcare

Enrollment

168 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections

Summary

The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety and how the body processes a new investigational drug called VH4011499, which is being developed as a potential HIV prevention tool (similar to PrEP). This phase tests the drug in healthy adults without HIV. **You may be eligible if...** - Age 18–55 and generally healthy - Do not have HIV - If you can become pregnant: not currently pregnant and not planning to become pregnant during the study; must use effective contraception **You may NOT be eligible if...** - You have HIV - Have significant health conditions (heart, liver, kidney disease, etc.) - Are pregnant or breastfeeding - Are taking medications that could interact with the study drug 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

DRUGVH4011499 low dose Injection

VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.

DRUGVH4011499 high dose Injection

VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.

DRUGPlacebo

Placebo Injection will be administered either subcutaneously or intramuscularly.

Locations(2)

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Austin, Texas, United States

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NCT06724640

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