A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants

NCT07525544 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 300109
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Keywords

First-Time-in-Human; Safety; Tolerability; Pharmacokinetics; Healthy participants; Human immunodeficiency virus (HIV); VH4770359 (GSK4770359); Oral

Outcome Measures

Primary Outcomes (1)

• Number of participants with Grade 3 and Grade 4 adverse events (AEs)

  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.

  From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks)

Secondary Outcomes (2)

• Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration

  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)

• Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration

  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)

Study Arms (6)

Part A: VH4770359 SAD group

EXPERIMENTAL

Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD).

Drug: VH4770359

Part A: Placebo SAD group

PLACEBO COMPARATOR

Healthy participants will receive a single dose of Placebo on Day 1.

Drug: Placebo

Part B: VH4770359 MAD group

EXPERIMENTAL

Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD).

Drug: VH4770359

Part B: Placebo MAD group

PLACEBO COMPARATOR

Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14.

Drug: Placebo

Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group

EXPERIMENTAL

Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Drug: VH4770359; Drug: Midazolam

Part B: Placebo MAD DDI group

PLACEBO COMPARATOR

Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Drug: Placebo; Drug: Midazolam

Interventions

VH4770359 DRUG

Participants will receive the assigned dose formulation of VH4770359 orally.

Part A: VH4770359 SAD group; Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group; Part B: VH4770359 MAD group

Placebo DRUG

Participants will receive placebo to match the VH4770359 dose formulation.

Part A: Placebo SAD group; Part B: Placebo MAD DDI group; Part B: Placebo MAD group

Midazolam DRUG

Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Part B: Placebo MAD DDI group; Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years old
• BMI 18.5-37.0 kg/m2
• Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.

You may not qualify if:

• Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
• A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
• A history of or ongoing high-risk behaviors for HIV acquisition.
• Use of prohibited medications.
• Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.

Sponsors & Collaborators

• ViiV Healthcare: lead

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.