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Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID06724640

Phase 1 Study of VH4011499 Safety, Tolerability, and Pharmacokinetics with Single and Multiple Doses in Adults Without HIV

Led by ViiV Healthcare · Updated on 2025-10-29

168

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, tolerability, and how the body processes VH4011499 when given in single or multiple doses to adults without HIV. This Phase 1 trial aims to understand how the drug behaves in healthy adults aged 18 to 55 and to monitor any side effects or reactions over time. Participants will be randomly assigned to receive either a low or high dose of VH4011499 or a placebo. The drug is given by injection, either under the skin or into the muscle. Some participants will receive a single dose while others will get multiple doses. The study includes an initial dosing period and long-term follow-up extending up to 78 weeks. During the study, participants will undergo regular assessments including blood tests to measure drug levels and liver function, as well as monitoring for any side effects such as injection site reactions. Researchers will track safety over time and collect data on how the drug is absorbed and eliminated. Participation involves visits over many months to evaluate these outcomes carefully.

CONDITIONS

Brief Title

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

Research Team

U

US GSK Clinical Trials Call Center

E

EU GSK Clinical Trials Call Center

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