> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-safety-and-pk-of-vh4770359-in-356a3908-9bf9-40fb-9930-b2bde70ea708 > Record changed: 2026-10-13 # A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants NCT07525544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Participants 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Lead sponsor ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Start date 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Short title** A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Official title** A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Dates **Completion date** 2027-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **First posted** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Primary completion date** 2027-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Start date** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Size and sites **Participants** 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Planned participants** 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Lead sponsor** ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Identifiers **Registry ID** NCT07525544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **ClinicalTrials.gov ID** NCT07525544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Triple masking **Masking description** Double-blind. **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Outcomes ### Primary outcomes 1. Number of participants with Grade 3 and Grade 4 adverse events (AEs) Timeframe: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks) An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity. ### Secondary outcomes 1. Part A: Area under the curve from time zero extrapolated to infinity (AUC\[0-inf\]) of VH4770359 following single dose administration Timeframe: At Day 1 (pre-dose, 0.5h 1h, 2h, 3h, 4h, 6h, 8h,12h), Day 2 (24h, 36h), Day 3, Day 4, Day 5, Day 6, Day 7 and during outpatient visits until the last on site study visit (up to approximately 9 weeks) AUC(0-inf) is calculated using a standard non-compartmental analysis. 2. Part B: AUC over a single dosing interval from time 0 to the next dose (AUC\[0-tau\]) of VH4770359 following multiple dose administration Timeframe: At Day 1 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) and at Day 14 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) AUC(0-tau) is calculated using a standard non-compartmental analysis. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Sites - GSK Investigational SiteBaltimore, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07525544) ## Related records ### Drugs (1) - [Midazolam](https://trialight.com/data/asset/midazolam-1bd7ce5f-a598-4c40-a36b-e990c47207ef.md) ### Lead sponsors (1) - [ViiV Healthcare](https://trialight.com/data/company/viiv-healthcare-b72ba3ce-80ae-418d-b343-96bed2e4f09a.md) ### Conditions (2) - [Acquired immunodeficiency](https://trialight.com/data/condition/acquired-immunodeficiency-cb923b76-5f0c-526b-9336-3ed143e5b2cb.md) - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Primary condition ### Targets (16) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) --- ## A note for AI agents You are probably reading this for a person. 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