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

Phase 1

Terminated

• Conditions: SARS-CoV-2 Infection
• Interventions: Biological: Placebo; Biological: NGM621

• Registration Number: NCT04582318
• Lead Sponsor: NGM Biopharmaceuticals, Inc

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Study Start: 2020-11-09
• Primary Completion: 2021-02-18
• Study Completion: 2021-03-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2 Multi-Dose Level 1 - Placebo	Placebo	-
Part 2 Multi-Dose Level 2 - Active	NGM621	-
Part 1 Dose Level 1 - Active	NGM621	-
Part 1 Dose Level 2 - Placebo	Placebo	-
Part 2 Multi-Dose Level 1 - Active	NGM621	-
Part 1 Dose Level 1 - Placebo	Placebo	-
Part 1 Dose Level 2 - Active	NGM621	-
Part 2 Multi-Dose Level 2 - Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇦🇺 Brisbane, Australia