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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-03-11

Brief Summary

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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).

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Detailed Description

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Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1 Dose Level 1 - Active

Group Type EXPERIMENTAL

NGM621

Intervention Type BIOLOGICAL

NGM621 will be administered via IV infusion

Part 1 Dose Level 1 - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo will be administered via IV infusion

Part 1 Dose Level 2 - Active

Group Type EXPERIMENTAL

NGM621

Intervention Type BIOLOGICAL

NGM621 will be administered via IV infusion

Part 1 Dose Level 2 - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo will be administered via IV infusion

Part 2 Multi-Dose Level 1 - Active

Group Type ACTIVE_COMPARATOR

NGM621

Intervention Type BIOLOGICAL

NGM621 will be administered via IV infusion

Part 2 Multi-Dose Level 1 - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo will be administered via IV infusion

Part 2 Multi-Dose Level 2 - Active

Group Type ACTIVE_COMPARATOR

NGM621

Intervention Type BIOLOGICAL

NGM621 will be administered via IV infusion

Part 2 Multi-Dose Level 2 - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo will be administered via IV infusion

Interventions

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NGM621

NGM621 will be administered via IV infusion

Intervention Type BIOLOGICAL

Placebo

Placebo will be administered via IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes