Recruiting
Phase 1

VH4770359

Sponsor:

ViiV Healthcare

Code:

NCT07525544

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

VH4770359

Placebo

Midazolam

Study Details

Brief 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

Study ID

NCT07525544

Start date

May 14, 2026

Status verified date

Jul, 2026

Completion date

May 5, 2027

Anticipated

Primary completion date

May 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18 to 55 years old
2. BMI 18.5-37.0 kg/m2
3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.

Exclusion Criteria:

1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.
3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
4. A history of or ongoing high-risk behaviors for HIV acquisition.
5. Use of prohibited medications.
6. Exclusionary allergies or sensitivities.
7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.
8. Exclusionary prior or concurrent clinical study participation.

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

VH4770359

Participants will receive the assigned dose formulation of VH4770359 orally.

Placebo

Participants will receive placebo to match the VH4770359 dose formulation.

Midazolam

Participants 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 and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Baltimore, Maryland, United States, 21225

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ronald Goldwater

More Information

Sponsor

ViiV Healthcare

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • First-Time-in-Human
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Healthy participants
  • Human immunodeficiency virus (HIV)
  • VH4770359 (GSK4770359)
  • Oral

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ViiV Healthcare on 2026-07-13.