NCT07525544 A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
| NCT ID | NCT07525544 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ViiV Healthcare |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2027-05-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 214 participants in total. It began in 2026-05-14 with a primary completion date of 2027-05-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07525544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07525544 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07525544 currently recruiting?
Yes, NCT07525544 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07525544 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07525544 clinical trial?
NCT07525544 is sponsored by ViiV Healthcare. The trial plans to enroll 214 participants.
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