← Back to Search

HIV-1 Capsid Inhibitor

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing a new HIV drug called VH4011499 in healthy adults. The drug aims to block a key part of the virus to stop it from working. The study will check if the drug is safe and how the body handles it.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection
  • HIV Suppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3 (Single dose): Participants receiving VH4011499 (new formulation)Experimental Treatment1 Intervention
Group II: Part 2 (MAD) Non DDI cohort: Participants receiving VH4011499Experimental Treatment1 Intervention
Group III: Part 2 (MAD) Drug-Drug Interaction (DDI) cohort: Participants receiving VH4011499 + MidazolamExperimental Treatment2 Interventions
Group IV: Part 1 (SAD): Participants receiving VH4011499Experimental Treatment1 Intervention
Group V: Part 1 (SAD): Participants receiving placeboPlacebo Group1 Intervention
Group VI: Part 2 (MAD) DDI cohort: Participants receiving placebo + MidazolamPlacebo Group2 Interventions
Group VII: Part 2 (MAD) Non DDI cohort: Participants receiving placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH4011499
2022
Completed Phase 2
~120
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
375 Previous Clinical Trials
470,709 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,608 Previous Clinical Trials
6,145,391 Total Patients Enrolled
~21 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top