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.
This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19. Participants will receive a single intravenous (IV) infusion dose of GIGA-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (Day 56).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Recombinant Hyperimmune Polyclonal Antibody
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Incidence of treatment-emergent adverse events (TEAEs)
Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Day 1 up to Day 56
Incidence of dose limiting toxicities (DLTs)
Frequency of DLTs at each dose level
Time frame: Day 1 up to Day 3
Change from baseline of vital signs, physical examination, and clinical laboratory assessments
Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG
Time frame: Day 1 up to Day 56
Incidence of infusion-related reactions (IRR) and hypersensitivity reactions
Frequency of IRR and hypersensitivity reactions
Time frame: Day 1 through Day 2
Pharmacological evaluation of single doses of GIGA-2050
Serum titers of antibodies directed against SARS CoV-2 will be measured for the pharmacological profile of single doses of GIGA-2050
Time frame: Day 1 up to Day 28
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