Recent Updates
Recently added Catalysts

VH4367310

Phase 1

HIV Infections | Small molecule | Other |GSK plc|Last Updated: Sep 14, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

VH4367310 · 1 trial · 1 indication

Phase 1 1
NCT07818915A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult ParticipantsHIV Infections
NOT YET_RECRUITING112 Analytics
PHASE1NOT YET_RECRUITING
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.

Unlock Study Endpoints

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.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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...

Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 15, 2026NCT07818915NEW_TRIAL: changed
LOWSep 15, 2026NCT07818915NEW_TRIAL: changed
LOWSep 15, 2026NCT07818915NEW_TRIAL: changed