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VH5356136

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 16, 2026

Target and mechanism

ModalitySmall molecule

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

Clinical trial landscape

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