A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Part of paid clinical trials in Tempe, Arizona.
- Sponsor
- argenx
- Study ID
- NCT05817435
- Phase
- PHASE1
- Status
- Completed
Conditions
- Bioequivalence
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- efgartigimod PH20 SC as a prefilled syringe presentation — BIOLOGICALefgartigimod PH20 SC as a prefilled syringe presentation
- efgartigimod PH20 SC as a vial + syringe presentation — BIOLOGICALefgartigimod PH20 SC as a vial + syringe presentation
Study Details
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.
Key Dates
- Start date
- Mar 13, 2023
- Status verified
- Oct 2023
- Primary completion
- May 12, 2023
- Completion
- May 12, 2023
Study Design
- Enrollment
- 120 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Efgartigimod PH20 SC - prefilled syringeefgartigimod PH20 SC administered by a prefilled syringe
- Active Comparator: Efgartigimod PH20 SC - vial + syringeefgartigimod PH20 SC administered by a vial + syringe
Primary Outcome Measure
Primary PK parameters (Cmax) [ Time Frame: Up to 29 days ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Investigator site 0010209 | Tempe | Arizona | 85282 | - |
| Investigator site 0010208 | Lincoln | Nebraska | 68510 | - |
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