HIV InfectionsPhase 1NCT07822477
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
A Phase 1 study testing VH5356136 Formulation 1 and VH5356136 Formulation 2 in people with HIV Infections, run by ViiV Healthcare.
Trial summary
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (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?
- VH5356136 Formulation 1 and VH5356136 Formulation 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2026to 9 May 2029
- 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
- Participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- 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).
- Participants of any sex (male or female) are eligible. A female participant (female sex assigned at birth) is eligible to participate if they are a person of non-childbearing potential (PONCBP).
- Capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- The criteria presented above represent a subset of the key inclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol.
Who cannot join
- History or presence of, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, 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.
- History of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates study participation.
- 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.
- Any preexisting physical or mental condition which, in the opinion of the investigator or the medical monitor, 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.
- Previous exposure to the parent molecule VH4524184.
- 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.
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- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Current enrolment or participation in another clinical study.
- Any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
- Positive HIV antibody/antigen test.
- History of clinically relevant hepatitis within the last 6 months.
- Positive hepatitis B or hepatitis C test.
- Clinically significant cardiovascular disease..
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 milliseconds (msec) and >480 msec (bundle branch block).
- Blood pressure (BP) >140/90 (systolic BP/diastolic BP [SBP/DBP]).
- Resting heart rate (HR) <50 or >100 beats per minute (bpm) when vital signs are measured at Screening or Check-in.
- The criteria presented above represent a subset of the key exclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Randomized, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Parenterally Administered VH5356136 in Adult Participants Without HIV
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.
- Conditions
- HIV Infections
- Being tested
- VH5356136 Formulation 1, VH5356136 Formulation 2, Placebo for VH5356136 Formulation 1, Placebo for VH5356136 Formulation 2
- Keywords
- VH5356136, VH4524184, Safety, Tolerability, HIV, Parenteral administration, Pharmacokinetics, Ascending Dose
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH5356136 Formulation 1Drug
Participants will receive VH5356136 Formulation 1 on Day 1.
VH5356136 Formulation 2Drug
Participants will receive VH5356136 Formulation 2 on Day 1.
Placebo for VH5356136 Formulation 1Drug
Participants will receive placebo for VH5356136 Formulation 1 on Day 1.
Placebo for VH5356136 Formulation 2Drug
Participants will receive placebo for VH5356136 Formulation 2 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| VH5356136 Formulation 1 | Experimental | Participants will receive a single dose of VH5356136 Formulation 1 administered on Day 1. Receives: Drug: VH5356136 Formulation 1 |
| Placebo for VH5356136 Formulation 1 | Placebo comparator | Participants will receive a single dose of placebo for VH5356136 Formulation 1 administered on Day 1. Receives: Drug: Placebo for VH5356136 Formulation 1 |
| VH5356136 Formulation 2 | Experimental | Participants will receive a single dose of VH5356136 Formulation 2 administered on Day 1. Receives: Drug: VH5356136 Formulation 2 |
| Placebo for VH5356136 Formulation 2 | Placebo comparator | Participants will receive a single dose of placebo for VH5356136 Formulation 2 administered on Day 1. Receives: Drug: Placebo for VH5356136 Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. A drug-related AE is an AE that, in the opinion of the investigator, is related to one of the study interventions.
Measured: From Day 1 to Month 18
Number of participants with Grade 2 to Grade 5 AEs
The grading of AEs is performed based on the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale, here Grade 2 = moderate, Grade 3=severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Measured: From Day 1 to Month 18
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.
Measured: From Day 1 to Month 18
Area under the concentration time curve from zero (pre-dose) to the last quantifiable concentration (post dose) (AUC[0-tlast]) for VH5356136
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
AUC(0-tlast) for VH4524184
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Maximum plasma concentration (Cmax) for VH5356136
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Cmax for VH4524184
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Time to maximum observed plasma drug concentration (tmax) for VH5356136
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Tmax for VH4524184
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Terminal half-life (t1/2) for VH5356136
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
t1/2 for VH4524184
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Secondary outcomes (1)
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
The laboratory abnormalities are assessed using the DAIDS grading scale, where Grade 3 = severe and Grade 4 = potentially life-threatening.
Measured: From Day 1 (pre-dose) up to Month 18 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start6 Nov 2026 (estimated)
- Primary completion9 May 2029 (estimated)
- Study completion9 May 2029 (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
- Parallel groups
- Model description
- Sequential Groups in a Parallel Design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 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
- NCT07822477
- Sponsor's protocol ID
- 300862
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- 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\_28May2026.pdf
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 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, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Parenterally Administered VH5356136 in Adult Participants Without HIV
- ClinicalTrials.gov ID
- NCT07822477
- Acronym / sponsor ID
- 300862
- Conditions
- HIV Infections
- Keywords
- VH5356136, VH4524184, Safety, Tolerability, HIV, Parenteral administration, Pharmacokinetics, Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 9 May 2029 (estimated)
- Study completion
- 9 May 2029 (estimated)
- First posted
- 16 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.
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Sequential Groups in a Parallel Design
| Arm | Type | Receives |
|---|---|---|
| VH5356136 Formulation 1 | Experimental | Drug: VH5356136 Formulation 1Participants will receive a single dose of VH5356136 Formulation 1 administered on Day 1. |
| Placebo for VH5356136 Formulation 1 | Placebo comparator | Drug: Placebo for VH5356136 Formulation 1Participants will receive a single dose of placebo for VH5356136 Formulation 1 administered on Day 1. |
| VH5356136 Formulation 2 | Experimental | Drug: VH5356136 Formulation 2Participants will receive a single dose of VH5356136 Formulation 2 administered on Day 1. |
| Placebo for VH5356136 Formulation 2 | Placebo comparator | Drug: Placebo for VH5356136 Formulation 2Participants will receive a single dose of placebo for VH5356136 Formulation 2 administered on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- 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).
- Participants of any sex (male or female) are eligible. A female participant (female sex assigned at birth) is eligible to participate if they are a person of non-childbearing potential (PONCBP).
Key exclusion criteria (18 listed)
- History or presence of, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, 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.
- History of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates study participation.
- 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.
- Any preexisting physical or mental condition which, in the opinion of the investigator or the medical monitor, 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.
- Previous exposure to the parent molecule VH4524184.
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 |
|---|---|---|
| VH5356136 Formulation 1Participants will receive VH5356136 Formulation 1 on Day 1. | Drug | VH5356136 Formulation 1 |
| VH5356136 Formulation 2Participants will receive VH5356136 Formulation 2 on Day 1. | Drug | VH5356136 Formulation 2 |
| Placebo for VH5356136 Formulation 1Participants will receive placebo for VH5356136 Formulation 1 on Day 1. | Drug | Placebo for VH5356136 Formulation 1 |
| Placebo for VH5356136 Formulation 2Participants will receive placebo for VH5356136 Formulation 2 on Day 1. | Drug | Placebo for VH5356136 Formulation 2 |
Primary outcome
Number of participants with drug-related adverse events (AEs)
Time frame: From Day 1 to Month 18
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. A drug-related AE is an AE that, in the opinion of the investigator, is related to one of the study interventions.
Number of participants with Grade 2 to Grade 5 AEs
Time frame: From Day 1 to Month 18
The grading of AEs is performed based on the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale, here Grade 2 = moderate, Grade 3=severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Number of participants with serious adverse events (SAEs)
Time frame: From Day 1 to Month 18
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.
Area under the concentration time curve from zero (pre-dose) to the last quantifiable concentration (post dose) (AUC[0-tlast]) for VH5356136
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
AUC(0-tlast) for VH4524184
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
Maximum plasma concentration (Cmax) for VH5356136
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
Cmax for VH4524184
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
Time to maximum observed plasma drug concentration (tmax) for VH5356136
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
Tmax for VH4524184
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
Terminal half-life (t1/2) for VH5356136
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
t1/2 for VH4524184
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
1 secondary outcome
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Time frame: From Day 1 (pre-dose) up to Month 18 post-dose
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 16 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH5356136 Formulation 1 and VH5356136 Formulation 2 in people with HIV Infections, run by ViiV Healthcare.
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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with drug-related adverse events (AEs) (time frame: From Day 1 to Month 18). The study lists 11 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 16 Sep 2026.