dMAbs for Prevention of COVID-19

Phase 1 Completed 61 enrolled Pablo Tebas AstraZeneca · collab Inovio Pharmaceuticals · collab The Wistar Institute · collab

Non-randomizedSequentialOpen-labelPrevention

Summary

This is a Phase 1, open-label, single center, dose escalation study to evaluate the safety, tolerability 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) or a 4-dose regimen (Days 0, 3, 28 and 31) 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.

Timeline

Start: 2022-05-19
Primary completion: 2025-06-11
Completion: 2025-11-21

Publications

Tebas P, Patel A, Agnes JT, Parzych EM, Baer A, Caturla M, Ghosh S, Purwar M, Bedanova N, Tsang C, Morales K, Amante D, Fisher PD, Francica JR, Humeau L, Kulp DW, Pallesen J, Leon P, Esser M, Smith TRF, Weiner DB. Safety and pharmacokinetics of SARS-CoV-2 DNA-encoded monoclonal antibodies in healthy adults: a phase 1 trial. Nat Med. 2025 Dec;31(12):4150-4159. doi: 10.1038/s41591-025-03969-0. Epub 2025 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD5396	Unknown	0.25 mg	Intramuscular
Subject	AZD5396	Unknown	0.5 mg	Intramuscular
Subject	AZD5396	Unknown	1 mg	Intramuscular
Subject	AZD5396	Unknown	2 mg	Intramuscular
Subject	AZD8076	Unknown	0.25 mg	Intramuscular
Subject	AZD8076	Unknown	0.5 mg	Intramuscular
Subject	AZD8076	Unknown	1 mg	Intramuscular
Subject	AZD8076	Unknown	2 mg	Intramuscular
Background	rHuPH20	Protein / enzyme biologic	—	—

Indications

No indication recorded.