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NCT05817435 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
A Phase 1 study of Bioequivalence, sponsored by argenx.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT05817435: Completed Phase 1 study of Bioequivalence, sponsored by argenx.
NCT05817435 is a Phase 1 study of Bioequivalence that has completed, run by argenx. The registered enrollment target is 120 participants, above the 32-participant average among 3 other Bioequivalence trials with a reported enrollment target (275% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05817435, a Phase 1 study of Bioequivalence, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
Primary Outcome
maximum observed plasma concentration
Conditions Studied
Interventions
- BIOLOGICAL efgartigimod PH20 SC as a prefilled syringe presentation
- BIOLOGICAL efgartigimod PH20 SC as a vial + syringe presentation
Study Locations (2)
Arizona
- Investigator site 0010209 - Tempe
Nebraska
- Investigator site 0010208 - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 1 |
What the finished NCT05817435 record still lists
NCT05817435 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 32-participant average among 3 other Bioequivalence trials with a reported enrollment target (275% higher).
The record links to 1 condition, with Bioequivalence appearing as the primary indexed condition, and to 2 interventions - of which efgartigimod PH20 SC as a prefilled syringe presentation is the first listed.
NCT05817435 reports a single indexed study location in Arizona, Nebraska.
Frequently Asked Questions
What is clinical trial NCT05817435 about?
NCT05817435 is a clinical study titled "A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults". This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
What is the current status of trial NCT05817435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2023-03-13. Estimated completion is 2023-05-12.
What conditions does trial NCT05817435 study?
This clinical trial studies the following conditions: Bioequivalence.
What interventions are being tested in trial NCT05817435?
The interventions under investigation include: efgartigimod PH20 SC as a prefilled syringe presentation (BIOLOGICAL), efgartigimod PH20 SC as a vial + syringe presentation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05817435?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05817435 being conducted?
This trial has 2 study locations across Arizona, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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