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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: Completed Phase 1 study, sponsored by AstraZeneca.
NCT05339100 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation of AUCinf following single SC administration of anifrolumab by AI is comparable to the AUCinf following single SC administration of anifrolumab using APFS will be done.
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 |
What the finished NCT05339100 record still lists
NCT05339100 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher).
The record links to 0 conditions, and to 3 interventions - of which Anifrolumab is the first listed.
NCT05339100 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05339100's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 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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