NCT07525544

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

A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4770359	Participants will receive the assigned dose formulation of VH4770359 orally.
DRUG	Placebo	Participants will receive placebo to match the VH4770359 dose formulation.
DRUG	Midazolam	Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Timeline

• Start date: 2026-04-07
• Primary completion: 2027-05-05
• Completion: 2027-05-05
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study