NCT07525544PHASE1RecruitingAccepts Healthy Volunteers
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
ViiV Healthcare
Start Date
5/14/2026
Completion Date
5/5/2027
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.
Eligibility Criteria
Age Range: 18 years to 55 years
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.
Interventions
DRUG
VH4770359
DRUG
Placebo
DRUG
Midazolam
Conditions
HIV Infections
Locations
GSK Investigational Site
Baltimore, Maryland 21225
United States