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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

First Time in Human Study of Long Acting VH4524184 Formulations

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults

First Time in Human Study of Long Acting VH4524184 Formulations (NCT06310551) is a Phase 1 interventional studying HIV Infections, sponsored by ViiV Healthcare. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For HIV Infections, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 268 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV Infections subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Age 1. Participant must be 18 to 55 years of age inclusive, at the time of signing the willing to sign a consent form. Type of Participant and Characteristics 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR). 4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. Weight 5. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except A11. For Cohort A11, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive). Sex and Contraceptive/Barrier Requirements 6. Male or female 1. Male Participants: No restrictions for male participants 2. Participants of female sex assigned at birth: - A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception. - A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met. willing to sign a consent form 7. Capable of providing signed willing to sign a consent form. Who Should NOT Join This Trial: Medical Conditions 1. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Age 1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Type of Participant and Characteristics 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR). 4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. Weight 5. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except A11. For Cohort A11, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive). Sex and Contraceptive/Barrier Requirements 6. Male or female 1. Male Participants: No restrictions for male participants 2. Participants of female sex assigned at birth: * A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception. * A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met. Informed Consent 7. Capable of providing signed informed consent. Exclusion Criteria: Medical Conditions 1. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits. 2. Clinically significant abnormal blood pressure as determined by the investigator. 3. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 4. Breast cancer within the past 10 years. 5. Current or chronic history of liver disease or known hepatic or biliary abnormalities. 6. Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome. 7. Underlying skin disease or disorder that would interfere with the administration of study product and/or assessment of injection site reactions. 8. Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of /sensitivity to any of the study interventions including hyaluronidases. 9. Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. 10. History of seizure. 11. Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances, at the discretion of the investigator. 12. Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening. 13. Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator. 14. Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and/or assessment of ISRs, if they occur. 15. History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use. Prior/Concomitant Therapy 16. Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study. 17. Receipt of any live vaccine(s) or vaccines against SARS-CoV-2 within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing. Prior/Concurrent Clinical Study Experience 18. Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day. 19. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study. 20. Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period. 21. Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803. Diagnostic Assessments 22. eGFR \<60 mL/min or serum creatinine \>1.1 x ULN. 23. Hemoglobin \<12.5 g/dL for men and \<11 g/dL for women 24. ALT or AST \>1.5x upper limit of normal (ULN) 25. Total bilirubin \>1.5xULN. 26. Any significant arrhythmia or ECG finding. 27. Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination. 28. Presence of HBsAg and/or anti-HBc at Screening or within 3 months prior to first dose of study intervention. 29. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. 30. Positive pre-study drug/alcohol screen. 31. Positive HIV antibody test. Other Exclusions 32. Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. 33. Regular use of known drugs of abuse. 34. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission. 35. Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.

Treatments Being Tested

DRUG

Oral VH4524184

VH4524184 to be taken orally.

DRUG

VH4524184 Formulation A SC

Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.

DRUG

Placebo Formulation A SC

Starting dose of Placebo Formulation A administered subcutaneously.

DRUG

rHuPH20

Dose of rHuPH20 administered subcutaneously.

DRUG

VH4524184 Formulation B SC

Starting dose of VH4524184 LAI Formulation B administered subcutaneously.

DRUG

Placebo Formulation B SC

Starting dose of Placebo Formulation B administered subcutaneously.

DRUG

VH4524184 Formulation A IM

Starting dose VH4524184 LAI Formulation A administered intramuscularly.

DRUG

Placebo Formulation A IM

Dose of Placebo Formulation A administered intramuscularly.

DRUG

VH4524184 Formulation B IM

Starting dose VH4524184 LAI Formulation B administered intramuscularly.

DRUG

Placebo Formulation B IM

Dose of Placebo Formulation B administered intramuscularly.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
San Antonio, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06310551), the sponsor (ViiV Healthcare), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06310551 clinical trial studying?

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06310551?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06310551?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06310551. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06310551. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.