Overview

dMAbs for Prevention of COVID-19

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, single center, dose escalation study to evaluate the safety and pharmacokinetic profile of mAb AZD5396 and mAb AZD8076 following delivery of optimized dMAb AZD5396 and dMAb AZD8076 with Hylenex® recombinant, administered by intramuscular injection (IM) followed immediately by electroporation (EP) using the CELLECTRA® 2000 with Side Port needle device, in a 2-dose regimen (Days 0 and 3) in healthy adults. The hypothesis is that the administration of dMAb AZD5396 and dMAb AZD8076 will be safe and associated with expression of mAb AZD5396 and mAb AZD8076 in serum.
Phase:
Phase 1
Details
Lead Sponsor:
Pablo Tebas
Collaborators:
AstraZeneca
Inovio Pharmaceuticals
The Wistar Institute
United States Department of Defense
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate