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

A Randomized, Double Blind, Placebo Controlled, Combined Phase 1/2 Single Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of NGM621 in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Subjects With Confirmed SARS-CoV-2 Infection

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04582318

Enrollment

Registered

2020-10-09

Start date

2020-11-09

Completion date

2021-03-11

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection

Brief summary

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).

Interventions

BIOLOGICALNGM621

NGM621 will be administered via IV infusion

BIOLOGICALPlacebo

Placebo will be administered via IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment emergent adverse events - Part 1	85 days	TEAEs in subjects receiving NGM621 compared to placebo
Treatment emergent adverse events - Part 2	91 days	TEAEs in subjects receiving NGM621 compared to placebo
Clinical status at Day 15 and Day 29 - Part 2	29 days	Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group

Secondary

Measure	Time frame
Maxiumum Serum Concentration [Cmax]	91 days
Change in Hemolytic Assays (CH50 and AH50) from Baseline	91 days
Mortality at Day 29	29 days
Duration of Supplemental Oxygen Requirement	91 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026