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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: 5 to 6 Study sites: 1 to 2 · Interventions: Placebo for VH4011499 Injection (Drug), VH4011499 Injection (Drug) to Placebo (Drug), VH4011499 high dose Injection (Drug), VH4011499 low dose Injection (Drug) · Eligibility criteria expanded, about 106 words · 1 morev5 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Interventions: Placebo for VH4011499 Injection (Drug), VH4011499 Injection (Drug) to Placebo (Drug), VH4011499 high dose Injection (Drug), VH4011499 low dose Injection (Drug)
    • Eligibility criteria expanded, about 106 words
    • Secondary endpoints: 7 to 11

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Mar 6, 2028 to Aug 16, 2028v4
  3. Completion date: Mar 6, 2028 to Aug 16, 2028v3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 1v2 Show 1 more changeShow less
    • Study sites: 2 to 1
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06724640
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov