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VH4367310

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Trials Updated: Oct 20, 2026

VH4367310 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

VH4367310 clinical trials

VH4367310 · 1 trial · 1 indication

Phase 1 1
NCT07818915A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult ParticipantsHIV Infections
RECRUITING112 Analytics
PHASE1RECRUITING
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB
Up to Week 72
Maximum observed plasma concentration (Cmax) of VH4367310 and CAB
Up to Week 72
Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB
Up to Week 72
Number of participants with drug-related adverse events (AEs)
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
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)
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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VH4367310 GroupEXPERIMENTALParticipants will be randomized to receive a single injection of VH4367310 on Day 1.
Placebo GroupPLACEBO_COMPARATORParticipants will be randomized to receive placebo on Day 1.

Interventions

NameTypeDescription
VH4367310DRUGVH4367310 will be administered intramuscularly.
PlaceboDRUGPlacebo will be administered intramuscularly.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * 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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 20, 2026NCT07818915Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 20, 2026NCT07818915Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 15, 2026NCT07818915NEW_TRIAL: changed
LOWSep 15, 2026NCT07818915NEW_TRIAL: changed
LOWSep 15, 2026NCT07818915NEW_TRIAL: changed

Frequently asked questions about VH4367310

What is VH4367310?

VH4367310 is an investigational small molecule drug being developed by GSK plc for HIV infections. It is in Phase 1 clinical development and is being studied in healthy adult volunteers to assess its pharmacokinetics, safety, and tolerability. It has not been established as an approved treatment.

What is VH4367310 used for in HIV?

VH4367310 is being studied for HIV infections as an investigational small molecule therapeutic. Its clinical program is at the Phase 1 stage, focused on early pharmacokinetic, safety, and tolerability evaluation in healthy adult participants rather than on confirmed treatment use in patients.

Who is developing VH4367310?

VH4367310 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 program evaluating the compound in HIV infections, with the clinical work conducted in the United States.

What phase is VH4367310 in?

VH4367310 is in Phase 1 clinical development. It is an investigational agent and is not approved for any use. The Phase 1 program is designed to investigate pharmacokinetics, safety, and tolerability in healthy adult participants.

What clinical trials is VH4367310 in?

VH4367310 is being studied in trial NCT07818915, titled A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants. This Phase 1 trial is currently recruiting, is placebo-controlled and double-blind, and plans to enroll 112 participants in the United States.

What are the design features of the VH4367310 Phase 1 trial?

The Phase 1 trial NCT07818915 is a randomized, double-blind, placebo-controlled study in healthy adult volunteers aged 18 years and older, open to all sexes. It plans to enroll 112 participants across sites in the United States and is currently recruiting.