Due to the rapidly changing therapeutic landscape in the COVID-19 space and an assessment of unmet medical need, Part 2 of the study was cancelled (per protocol Section 4.3). Meanwhile, Part 1 of the study was completed.

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).

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.

This is a proof-of-concept study assessing the safety, tolerability, PK, and efficacy of systemic use of NGM621 versus placebo in both healthy subjects and subjects confirmed with SARS-CoV-2 infection. We will continue to evaluate whether IPD will be shared with other researchers.