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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 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 73 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05163522
The ClinicalTrials.gov registry entry for NCT05163522 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. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05163522 reports 0 study locations.
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.
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