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

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).

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: NGM621; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • NGM Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1 Dose Level 1 - Active	Biological: NGM621; NGM621 will be administered via IV infusion
PLACEBO_COMPARATOR: Part 1 Dose Level 1 - Placebo	Biological: Placebo; Placebo will be administered via IV infusion
EXPERIMENTAL: Part 1 Dose Level 2 - Active	Biological: NGM621; NGM621 will be administered via IV infusion
PLACEBO_COMPARATOR: Part 1 Dose Level 2 - Placebo	Biological: Placebo; Placebo will be administered via IV infusion
ACTIVE_COMPARATOR: Part 2 Multi-Dose Level 1 - Active	Biological: NGM621; NGM621 will be administered via IV infusion
PLACEBO_COMPARATOR: Part 2 Multi-Dose Level 1 - Placebo	Biological: Placebo; Placebo will be administered via IV infusion
ACTIVE_COMPARATOR: Part 2 Multi-Dose Level 2 - Active	Biological: NGM621; NGM621 will be administered via IV infusion
PLACEBO_COMPARATOR: Part 2 Multi-Dose Level 2 - Placebo	Biological: Placebo; Placebo will be administered via IV infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2020
• Primary Completion (ACTUAL): February 18, 2021
• Study Completion (ACTUAL): March 11, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: 621-CP-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No