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
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- VH4770359 (drug)
- Placebo (drug)
- Midazolam (drug)
Sponsor: ViiV Healthcare · Participants: 214 · Started: May 14, 2026
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT07525544
Locations in the U.S.
| Maryland | GSK Investigational Site, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.