NCT04582318 is a Phase 1, PHASE2 clinical trial of NGM621 in SARS-CoV-2 Infection, sponsored by NGM Biopharmaceuticals, Inc.

Who is sponsoring NCT04582318?

NCT04582318 is sponsored by NGM Biopharmaceuticals, Inc.

What drugs are being tested in NCT04582318?

Interventions in NCT04582318: NGM621, Placebo.

What condition does NCT04582318 study?

NCT04582318 studies SARS-CoV-2 Infection.

Is NCT04582318 still recruiting?

NCT04582318 is currently terminated. Last updated 25 February 2022.

Last reviewed 2022-02-25 · How we verify

NCT04582318

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1, PHASE2 Last updated 25 February 2022

What this trial tests

Phase 1, PHASE2 trial testing NGM621 in SARS-CoV-2 Infection in 16 participants. Terminated before completion.

Timeline

9 November 2020

Primary endpoint
18 February 2021

11 March 2021

Quick facts

Lead sponsor	NGM Biopharmaceuticals, Inc
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	9 November 2020
Primary completion	18 February 2021
Estimated completion	11 March 2021
Sites	1 location across Australia

Drugs / interventions tested

NGM621 — full drug profile →
Placebo

Conditions studied

SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

NGM Biopharmaceuticals, Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic antibodies for COVID-19: is a new age of IgM, IgA and bispecific antibodies coming?
Zhang J, Zhang H, Sun L. · · 2022 · cited 21× · PMID 35220888 · DOI 10.1080/19420862.2022.2031483
Therapeutic Antibodies for the Treatment of Respiratory Tract Infections-Current Overview and Perspectives.
Mayor A, Chesnay A, Desoubeaux G, Ternant D, et al · · 2021 · cited 9× · PMID 33668613 · DOI 10.3390/vaccines9020151

Verify or expand the search:

Other trials of NGM621

Trials testing the same drug.

NCT04465955 — A Study of NGM621 in Participants With Geographic Atrophy · Phase 2 · completed
NCT04014777 — Study of NGM621 in Participants With Geographic Atrophy · Phase 1 · completed

Other recruiting trials for SARS-CoV-2 Infection

Currently open trials in the same condition.

NCT07079670 — Safety and Immunogenicity of NVX-CoV2705 · Phase 3 · active not recruiting
NCT05697068 — Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos · NA · active not recruiting
NCT05172011 — Understanding the Long-term Impact of COVID on Children and Families · active not recruiting
NCT05141058 — T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients · Phase 1 · recruiting
NCT05046470 — SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study · active not recruiting

Other NGM Biopharmaceuticals, Inc trials

Trials by the same sponsor.

NCT06654726 — A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary · Phase 2, PHASE3 · withdrawn
NCT07511972 — Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies · Phase 2 · withdrawn
NCT04828265 — Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects · Phase 1 · completed
NCT04823702 — Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function · Phase 1 · completed
NCT04465955 — A Study of NGM621 in Participants With Geographic Atrophy · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04582318 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NGM Biopharmaceuticals, Inc
Last refreshed: 25 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582318.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing