This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
NGM Clinical Study Site
Brisbane, Australia
Treatment emergent adverse events - Part 1
TEAEs in subjects receiving NGM621 compared to placebo
Time frame: 85 days
Treatment emergent adverse events - Part 2
TEAEs in subjects receiving NGM621 compared to placebo
Time frame: 91 days
Clinical status at Day 15 and Day 29 - Part 2
Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
Time frame: 29 days
Maxiumum Serum Concentration [Cmax]
Time frame: 91 days
Mortality at Day 29
Time frame: 29 days
Duration of Supplemental Oxygen Requirement
Time frame: 91 days
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Time frame: 91 days
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