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).
Biological: NGM621
NGM621 will be administered via IV infusion
Biological: Placebo
Placebo will be administered via IV infusion
Inclusion Criteria:
- Female subjects of childbearing potential must have a negative serum pregnancy test
result at Screening and a negative urine pregnancy test result prior to dosing.
- Female subjects of childbearing potential and male subjects with a female partner of
childbearing potential must use an effective method of contraception during the study,
for at least 1 month following study completion, and must not plan to become pregnant
for at least 1 month after her last study medication dose.
- BMI 18-32 kg/m2 inclusive
- Ability to understand and provide informed consent
- Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized
- If on mechanical support, less or equal than 2 days on mechanical ventilation or
oxygenation
Exclusion Criteria:
- Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection
- Known history of complement deficiency
- Active infection with, or history of, compllicated pneumococcal or Neisseria
meningitis infection or history of unexplained, recurrent infection, within the last
60 days prior to dosing.
NGM Clinical Study Site
Brisbane, Australia