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VH5356136

Phase 1

HIV Infections | Small Molecules | Infectious Disease |GSK plc|Trials Updated: Sep 16, 2026

VH5356136 target and mechanism

ModalitySmall Molecules

Also known as VH5356136 Formulation 1, VH5356136 Formulation 2

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

VH5356136 clinical trials

VH5356136 · 1 trial · 1 indication

Phase 1 1
NCT07822477A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIVHIV Infections
NOT YET_RECRUITING160 Analytics
PHASE1NOT YET_RECRUITING
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with drug-related adverse events (AEs)
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
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)
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
From Day 1 (pre-dose) up to Month 18 post-dose
AUC(0-tlast) for VH4524184
From Day 1 (pre-dose) up to Month 18 post-dose
Maximum plasma concentration (Cmax) for VH5356136
From Day 1 (pre-dose) up to Month 18 post-dose
Cmax for VH4524184
From Day 1 (pre-dose) up to Month 18 post-dose
Time to maximum observed plasma drug concentration (tmax) for VH5356136
From Day 1 (pre-dose) up to Month 18 post-dose
Tmax for VH4524184
From Day 1 (pre-dose) up to Month 18 post-dose
Terminal half-life (t1/2) for VH5356136
From Day 1 (pre-dose) up to Month 18 post-dose
t1/2 for VH4524184
From Day 1 (pre-dose) up to Month 18 post-dose

Secondary Endpoints

Number of participants with Grade 3 and Grade 4 laboratory abnormalities
From Day 1 (pre-dose) up to Month 18 post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VH5356136 Formulation 1EXPERIMENTALParticipants will receive a single dose of VH5356136 Formulation 1 administered on Day 1.
Placebo for VH5356136 Formulation 1PLACEBO_COMPARATORParticipants will receive a single dose of placebo for VH5356136 Formulation 1 administered on Day 1.
VH5356136 Formulation 2EXPERIMENTALParticipants will receive a single dose of VH5356136 Formulation 2 administered on Day 1.
Placebo for VH5356136 Formulation 2PLACEBO_COMPARATORParticipants will receive a single dose of placebo for VH5356136 Formulation 2 administered on Day 1.

Interventions

NameTypeDescription
VH5356136 Formulation 1DRUGParticipants will receive VH5356136 Formulation 1 on Day 1.
VH5356136 Formulation 2DRUGParticipants will receive VH5356136 Formulation 2 on Day 1.
Placebo for VH5356136 Formulation 1DRUGParticipants will receive placebo for VH5356136 Formulation 1 on Day 1.
Placebo for VH5356136 Formulation 2DRUGParticipants will receive placebo for VH5356136 Formulation 2 on Day 1.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * 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. * ...

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Recent Changes (Last 90 Days)

LOWSep 16, 2026NCT07822477NEW_TRIAL: changed
LOWSep 16, 2026NCT07822477NEW_TRIAL: changed

Frequently asked questions about VH5356136

What is VH5356136?

VH5356136 is an investigational small molecule being developed by GSK plc for HIV infections. It is in Phase 1 clinical development and has not been approved by any regulatory authority. It is being studied in adult participants without HIV to assess its safety, tolerability, and pharmacokinetics.

What is VH5356136 used for?

VH5356136 is being developed for the treatment or prevention of HIV infections. It is an investigational agent and is not approved for any use. Its only clinical study to date enrolls healthy adult volunteers without HIV, so its role in HIV care has not yet been established.

Who makes VH5356136?

VH5356136 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 study evaluating the compound. The drug is an investigational small molecule and is not yet commercially available.

What phase is VH5356136 in?

VH5356136 is in Phase 1 clinical development. One Phase 1 trial has been registered and is not yet recruiting, with no completed trials. Because it remains investigational, VH5356136 is not FDA approved and is not available outside of clinical research.

What clinical trials is VH5356136 in?

VH5356136 is being evaluated in one registered Phase 1 trial, NCT07822477, titled a study to investigate safety, tolerability and pharmacokinetics of VH5356136 in adult participants without HIV. The trial is not yet recruiting, plans to enroll 160 participants, and is randomized, double-blind, and placebo-controlled.

Is VH5356136 the same as VH5356136 Formulation 1 or Formulation 2?

Yes. VH5356136 Formulation 1 and VH5356136 Formulation 2 are alternative names for the same investigational compound, VH5356136. These names refer to different formulations of the drug studied in the same Phase 1 program, so searches for either formulation name point to the same asset.