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NCT05339100 · ClinicalTrials.gov registry record · Phase 1
Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT05339100 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 180 participants.
The verdict
NCT05339100, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
Interventions
- DRUG Anifrolumab
- DEVICE Autoinjector
- DEVICE Accessorized Pre-Filled Syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2023-04-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05339100
The ClinicalTrials.gov registry entry for NCT05339100 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Anifrolumab is the first listed.
NCT05339100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05339100 about?
NCT05339100 is a clinical study titled "Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab". This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
What is the current status of trial NCT05339100?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2022-03-22. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT05339100?
The interventions under investigation include: Anifrolumab (DRUG), Autoinjector (DEVICE), Accessorized Pre-Filled Syringe (DEVICE).
Who is sponsoring clinical trial NCT05339100?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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