Phase 1 Study to Assess Safety, Tolerability, and Drug Behavior of VH4770359 in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating VH4770359, an antiretroviral drug, in a first-in-human study to assess its safety, tolerability, and how the body processes it pharmacokinetics in healthy adults. This Phase 1 trial aims to gather information that will help design future studies of VH4770359 in people living with HIV. The study is sponsored by ViiV Healthcare and involves healthy participants aged 18 to 55 years. Participants will receive either a single dose or 14 daily doses of VH4770359 or a matching placebo. Some groups will also receive 2 mg of Midazolam on specific days to evaluate drug interactions. The study uses a randomized, triple-blind design with several cohorts receiving ascending doses to examine different dosing schedules. The treatment periods include single ascending doses SAD and multiple ascending doses MAD, with follow-up visits extending up to about 9 weeks. During the trial, participants will be closely monitored for adverse effects from the first dose until the last on-site visit. Blood samples will be collected at various times to measure drug levels and study pharmacokinetics. Researchers will track severe adverse events Grade 3 and 4 and measure drug exposure over time. Participants can expect regular assessments, including safety evaluations and laboratory tests, throughout the study duration, which lasts several weeks after dosing.

A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants