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NCT05393271 · ClinicalTrials.gov registry record · Phase 1
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 2
- Study locations
NCT05393271 is a Phase 1 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 73 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05393271, a Phase 1 study of HIV Infections, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 2
- Study locations
Study Summary
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG VH4011499
Study Locations (2)
Nevada
- GSK Investigational Site - Las Vegas
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2023-04-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05393271
The ClinicalTrials.gov registry entry for NCT05393271 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05393271 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT05393271 about?
NCT05393271 is a clinical study titled "First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants". This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate mu...
What is the current status of trial NCT05393271?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2022-10-03. Estimated completion is 2023-04-24.
What conditions does trial NCT05393271 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT05393271?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), VH4011499 (DRUG).
Who is sponsoring clinical trial NCT05393271?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05393271 being conducted?
This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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