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NCT05163522 · ClinicalTrials.gov registry record · Phase 1
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT05163522: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT05163522 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05163522, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.
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. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minim
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG VH4004280
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 1 |
What the finished NCT05163522 record still lists
NCT05163522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05163522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05163522 about?
NCT05163522 is a clinical study titled "First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 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 VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multi...
What is the current status of trial NCT05163522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2021-12-13. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05163522?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), VH4004280 (DRUG).
Who is sponsoring clinical trial NCT05163522?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05163522's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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