HIV InfectionsPhase 1NCT06724640
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
A Phase 1 study testing VH4011499 low dose Injection and VH4011499 high dose Injection in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.
Trial summary
The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4011499 low dose Injection and VH4011499 high dose Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2024to 16 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy.
- Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies:
- Is a Participant of Nonchildbearing potential (PONCBP)
- Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.
- Capable of giving signed informed consent.
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Abnormal blood pressure.
- 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.
- Breast cancer within the past 10 years.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- History of clinically relevant hepatitis within last 6 months.
Show all 21Show fewer
- Patients with chronic hepatitis B infection.
- History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
- The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
- Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded.
- History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition.
- Any preexisting physical or mental condition which may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
- Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing
- Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
- Current enrollment or recent past participation in another investigational study.
- Positive HIV antibody/antigen test.
- ALT more than or equal to (>=)1.5x upper limit of normal (ULN), Total bilirubin >=1.5x ULN (isolated total bilirubin more than (>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (<)60 millilitre per minute (mL/min)/1.73 square meter (m^2).
- Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec.
- Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (>3 seconds).
- The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Austin, Texas, 78744
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89113
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV
The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.
- Conditions
- HIV Infections
- Being tested
- VH4011499 low dose Injection, VH4011499 high dose Injection, Placebo
- Keywords
- Human Immunodeficiency Virus (HIV), VH4011499, Safety, Tolerability, Pharmacokinetics, Healthy participants, Long-Acting Injection, Single ascending dose, Multiple ascending dose
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4011499 low dose InjectionDrug
VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
VH4011499 high dose InjectionDrug
VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
PlaceboDrug
Placebo Injection will be administered either subcutaneously or intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose (SAD) Group | Experimental | Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo. Receives: Drug: VH4011499 low dose Injection; Drug: VH4011499 high dose Injection; Drug: Placebo |
| Multiple ascending doses (MAD) Group | Experimental | Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo. Receives: Drug: VH4011499 low dose Injection; Drug: VH4011499 high dose Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Measured: Up to Week 78
Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group
Measured: Up to Week 78
Area under the plasma concentration vs time curve (AUC0-tau) for MAD group
Measured: Up to Week 78
Maximum observed plasma concentration (Cmax) of VH4011499
Measured: Up to Week 78
Time to maximum observed plasma concentration (tmax) of VH4011499
Measured: Up to Week 78
Apparent terminal half-life (t1/2) of VH4011499
Measured: Up to Week 78
Secondary outcomes (11)
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group
Measured: At Day 4, Day 10, Week 4, Week 24 and Week 48
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for MAD group
Measured: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for SAD group
Measured: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for MAD group
Measured: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1)
Number of participants with maximum toxicity grade change from baseline in liver chemistry parameters: total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)
Measured: Baseline (Prior to Day 1) and Up to Week 78
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for SAD group
Measured: At Day 4, Day 10, Week 4, Week 24 and Week 48
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for MAD group
Measured: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for SAD group
Measured: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for MAD group
Measured: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1)
Number of participants with Grade 1 AEs (including ISR AEs) as per severity using the DAIDS grading scale
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Measured: Week 78 post dose (Week 82 for MAD Group)
Duration of ISR (Days) AEs by grade using the DAIDS grading scale
Measured: Week 78 post dose (Week 82 for MAD Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start16 Dec 2024
- Primary completion16 Aug 2028 (estimated)
- Study completion16 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724640
- Sponsor's protocol ID
- 218547
- Status last verified
- Oct 2025
- First submitted
- 4 Dec 2024
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV
- ClinicalTrials.gov ID
- NCT06724640
- Acronym / sponsor ID
- 218547
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus (HIV), VH4011499, Safety, Tolerability, Pharmacokinetics, Healthy participants, Long-Acting Injection, Single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 16 Aug 2028 (estimated)
- Study completion
- 16 Aug 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose (SAD) Group | Experimental | Drug: VH4011499 low dose Injection, Drug: VH4011499 high dose Injection, Drug: PlaceboParticipants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo. |
| Multiple ascending doses (MAD) Group | Experimental | Drug: VH4011499 low dose Injection, Drug: VH4011499 high dose Injection, Drug: PlaceboParticipants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy.
- Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies:
- Capable of giving signed informed consent.
Key exclusion criteria (21 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Abnormal blood pressure.
- 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.
- Breast cancer within the past 10 years.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4011499 low dose InjectionVH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly. | Drug | Multiple ascending doses (MAD) Group, Single ascending dose (SAD) Group |
| VH4011499 high dose InjectionVH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly. | Drug | Multiple ascending doses (MAD) Group, Single ascending dose (SAD) Group |
| PlaceboPlacebo Injection will be administered either subcutaneously or intramuscularly. | Drug | Multiple ascending doses (MAD) Group, Single ascending dose (SAD) Group |
Primary outcome
Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale
Time frame: Up to Week 78
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group
Time frame: Up to Week 78
Area under the plasma concentration vs time curve (AUC0-tau) for MAD group
Time frame: Up to Week 78
Maximum observed plasma concentration (Cmax) of VH4011499
Time frame: Up to Week 78
Time to maximum observed plasma concentration (tmax) of VH4011499
Time frame: Up to Week 78
Apparent terminal half-life (t1/2) of VH4011499
Time frame: Up to Week 78
11 secondary outcomes
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for MAD group
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for SAD group
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for MAD group
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1)
Number of participants with maximum toxicity grade change from baseline in liver chemistry parameters: total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)
Time frame: Baseline (Prior to Day 1) and Up to Week 78
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for SAD group
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for MAD group
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for SAD group
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for MAD group
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1)
Number of participants with Grade 1 AEs (including ISR AEs) as per severity using the DAIDS grading scale
Time frame: Week 78 post dose (Week 82 for MAD Group)
Duration of ISR (Days) AEs by grade using the DAIDS grading scale
Time frame: Week 78 post dose (Week 82 for MAD Group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH4011499 low dose Injection and VH4011499 high dose Injection in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale (time frame: Up to Week 78). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.