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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
ViiV Healthcare
Study ID
NCT07525544
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
May 14, 2026
Status verified
Jul 2026
Primary completion
May 5, 2027
Completion
May 5, 2027

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: VH4770359 SAD group
    Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD).
  • Placebo Comparator: Part A: Placebo SAD group
    Healthy participants will receive a single dose of Placebo on Day 1.
  • Experimental: Part B: VH4770359 MAD group
    Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD).
  • Placebo Comparator: Part B: Placebo MAD group
    Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14.
  • Experimental: Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group
    Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
  • Placebo Comparator: Part B: Placebo MAD DDI group
    Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Primary Outcome Measure

Number of participants with Grade 3 and Grade 4 adverse events (AEs) [ Time Frame: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBaltimoreMaryland21225
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Ronald Goldwater (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
HIV
By specialty
Infectious disease
By research site
GSK Investigational Site· Baltimore, MD

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