A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19

NGM Biopharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: SARS-CoV-2 Infection

Treatments: Biological: NGM621; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04582318

621-CP-102

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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16 participants in 8 patient groups, including a placebo group

Part 1 Dose Level 1 - Active

Experimental group

Treatment:

Biological: NGM621

Part 1 Dose Level 1 - Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

Part 1 Dose Level 2 - Active

Experimental group

Treatment:

Biological: NGM621

Part 1 Dose Level 2 - Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

Part 2 Multi-Dose Level 1 - Active

Active Comparator group

Treatment:

Biological: NGM621

Part 2 Multi-Dose Level 1 - Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

Part 2 Multi-Dose Level 2 - Active

Active Comparator group

Treatment:

Biological: NGM621

Part 2 Multi-Dose Level 2 - Placebo

Placebo Comparator group

Treatment:

Biological: Placebo