Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients

Phase 1 Terminated 3 enrolled GigaGen, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.

Timeline

Start: 2021-05-24
Primary completion: 2022-01-11
Completion: 2022-01-11

Outcome

Outcome not reported

Stopped: “Study stopped for commercial reasons.”

Publications

Background Keating SM, Mizrahi RA, Adams MS, Asensio MA, Benzie E, Carter KP, Chiang Y, Edgar RC, Gautam BK, Gras A, Leong J, Leong R, Lim YW, Manickam VA, Medina-Cucurella AV, Niedecken AR, Saini J, Simons JF, Spindler MJ, Stadtmiller K, Tinsley B, Wagner EK, Wayham N, Tracy L, Lundberg CV, Buscher D, Terencio JV, Roalfe L, Pearce E, Richardson H, Goldblatt D, Ramjag AT, Carrington CVF, Simmons G, Muench MO, Chamow SM, Monroe B, Olson C, Oguin TH, Lynch H, Jeanfreau R, Mosher RA, Walch MJ, Bartley CR, Ross CA, Meyer EH, Adler AS, Johnson DS. Generation of recombinant hyperimmune globulins from diverse B-cell repertoires. Nat Biotechnol. 2021 Aug;39(8):989-999. doi: 10.1038/s41587-021-00894-8. Epub 2021 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GIGA-2050	Protein / enzyme biologic	5 mg/kg	Intravenous
Subject	GIGA-2050	Protein / enzyme biologic	15 mg/kg	Intravenous
Subject	GIGA-2050	Protein / enzyme biologic	50 mg/kg	Intravenous