First-in-human test of VH4770359 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of oral VH4770359 in healthy participants aged 18 to 55. The trial includes VH4770359, placebo, and midazolam as a control. Findings will guide future studies of VH4770359 in people living with HIV. The study excludes individuals with significant medical or psychiatric conditions or factors that could alter drug levels or safety. Enrollment is limited to adults without active HIV infection and with appropriate contraception where applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• GSK Investigational Site
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.