A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
ViiV Healthcare
Study ID
NCT06724640
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • VH4011499 low dose Injection — DRUG
    VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
  • VH4011499 high dose Injection — DRUG
    VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
  • Placebo — DRUG
    Placebo Injection will be administered either subcutaneously or intramuscularly.

Study Details

The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.

Key Dates

Start date
Dec 16, 2024
Status verified
Oct 2025
Primary completion
Aug 16, 2028
Completion
Aug 16, 2028

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single ascending dose (SAD) Group
    Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo.
  • Experimental: Multiple ascending doses (MAD) Group
    Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo.

Primary Outcome Measure

Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale [ Time Frame: Up to Week 78 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLas VegasNevada89113
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Shawn Searle (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAustinTexas78744
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Jia Wen Chang (PRINCIPAL_INVESTIGATOR)

Find similar trials in Las Vegas, NV

By condition
HIV
By specialty
Infectious disease
By research site
GSK Investigational Site· Las Vegas, NVGSK Investigational Site· Austin, TX

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