HIV InfectionsPhase 1NCT07818915
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
A Phase 1 study testing VH4367310 in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.
Trial summary
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age. 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?
- VH4367310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2026to 26 Dec 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 greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years of age, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation.
- Body weight >=40 kg and BMI within the range >=18 to <=32 kg/m^2.
- Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during the study intervention period and for at least 90 days after the last dose of study intervention. Participants assigned female at birth are eligible to participate if they are a participant of non-childbearing potential (PONCBP).
- Capable of giving written informed consent.
Who cannot join
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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.
- 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.
- Unstable liver disease or known hepatic or biliary abnormalities.
- History of clinically relevant hepatitis within last 6 months.
- History of cirrhosis with or without viral hepatitis co-infection.
- Participants determined by the investigator to have a high risk of seizures.
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- Participant who poses a significant suicidality risk.
- Current or anticipated need for chronic anti-coagulation therapy.
- Hereditary coagulation or platelet disorders.
- Any acute laboratory abnormality at screening that would preclude participation or exclusionary laboratory value.
- Abnormal blood pressure.
- ALT >1.5x upper limit of normal (ULN). Total bilirubin >1.5x ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5x ULN as long as direct bilirubin is <=1.5x ULN.
- Hemoglobin <12.5 g/dL for men and <11 g/dL for women.
- Creatinine clearance (eGFR) of <60 millilitre per minute (mL/min)/1.73 square meter (m^2).
- Presence of HbsAg and/or HbcAb at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive HIV antibody/antigen test (HIV-1 ± HIV-2).
- Current enrolment or past participation in another investigational study in which an experimental drug or experimental vaccine was administered.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Past participation in another investigational clinical study in which long-acting CAB was administered or any CAB use for pre-exposure prophylaxis (PrEP).
- History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or another allergy.
- Participant has an implant/enhancement (including fillers); or tattoo or other dermatological condition overlying the area for IM or SC injection or any other area which may significantly interfere with interpretation of injection site reactions.
- History of or ongoing high-risk behaviors that may put the participant at increased risk for HIV.
- 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.
- Regular use of known drugs of abuse.
- Positive pre-study drug/alcohol screen.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
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
Baltimore, Maryland, 21225
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, (0) 20 8990 4466 ext. +44, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Glendale, California, 91206
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, (0) 20 8990 4466 ext. +44, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1 Double-blind (Sponsor-unblinded), Placebo-controlled, Randomized, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VH4367310 Administered to Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Conditions
- HIV Infections
- Being tested
- VH4367310, Placebo
- Keywords
- Pharmacokinetics, Safety, Tolerability, Cabotegravir, VH4367310, Healthy adults
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4367310Drug
VH4367310 will be administered intramuscularly.
PlaceboDrug
Placebo will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| VH4367310 Group | Experimental | Participants will be randomized to receive a single injection of VH4367310 on Day 1. Receives: Drug: VH4367310 |
| Placebo Group | Placebo comparator | Participants will be randomized to receive placebo on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB
Measured: Up to Week 72
Maximum observed plasma concentration (Cmax) of VH4367310 and CAB
Measured: Up to Week 72
Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB
Measured: Up to Week 72
Number of participants with drug-related adverse events (AEs)
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.
Measured: Up to Week 72
Number of participants with AEs as per severity
Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = Death.
Measured: Up to Week 72
Number of participants with drug-related serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2026
- Primary completion26 Dec 2028 (estimated)
- Study completion26 Dec 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 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
- NCT07818915
- Sponsor's protocol ID
- 221875
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- 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\_28May2026.pdf
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. 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 Evaluate the Pharmacokinetics, Safety, and Tolerability of VH4367310 Administered to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07818915
- Acronym / sponsor ID
- 221875
- Conditions
- HIV Infections
- Keywords
- Pharmacokinetics, Safety, Tolerability, Cabotegravir, VH4367310, Healthy adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 26 Dec 2028 (estimated)
- Study completion
- 26 Dec 2028 (estimated)
- First posted
- 14 Sep 2026 (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.
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VH4367310 Group | Experimental | Drug: VH4367310Participants will be randomized to receive a single injection of VH4367310 on Day 1. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive placebo on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years of age, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation.
- Body weight >=40 kg and BMI within the range >=18 to <=32 kg/m^2.
- Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during the study intervention period and for at least 90 days after the last dose of study intervention. Participants assigned female at birth are eligible to participate if they are a participant of non-childbearing potential (PONCBP).
- Capable of giving written informed consent.
Key exclusion criteria (30 listed)
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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.
- 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.
- Unstable liver disease or known hepatic or biliary abnormalities.
- History of clinically relevant hepatitis within last 6 months.
- History of cirrhosis with or without viral hepatitis co-infection.
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 |
|---|---|---|
| VH4367310VH4367310 will be administered intramuscularly. | Drug | VH4367310 Group |
| PlaceboPlacebo will be administered intramuscularly. | Drug | Placebo Group |
Primary outcome
Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB
Time frame: Up to Week 72
Maximum observed plasma concentration (Cmax) of VH4367310 and CAB
Time frame: Up to Week 72
Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB
Time frame: Up to Week 72
Number of participants with drug-related adverse events (AEs)
Time frame: Up to Week 72
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.
Number of participants with AEs as per severity
Time frame: Up to Week 72
Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = Death.
Number of participants with drug-related serious adverse events (SAEs)
Time frame: Up to Week 72
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
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 20 Oct 2026.
- 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_28May2026.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 VH4367310 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 5 inclusion and 30 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 20 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB (time frame: Up to Week 72). 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 20 Oct 2026.