CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
VH4004280 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05163522
NCT05163522Phase 1Completed
CompareCT.gov

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4004280 in Healthy Participants

ViiV Healthcare·interventional·Posted Dec 20, 2021·Updated Jul 30, 2025

In Brief

A Phase 1 clinical trial evaluating VH4004280, Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 73 participants across 1 site.

Detailed Summary

This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedDec 20, 2021
Enrollment StartDec 13, 2021
Primary CompletionJun 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.5 years ago

Interventions

VH4004280drug

VH4004280 will be administered.

Placebodrug

Placebo will be administered.

Midazolamdrug

Midazolam will be administered