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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: Completed Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
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 |
What the finished NCT05393271 record still lists
NCT05393271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05393271's enrollment target sits among peer trials
73 310th of 542 higher than 233 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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