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
Primary Purpose
SARS-CoV-2 Infection
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
NGM621
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
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.
Sites / Locations
- NGM Clinical Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Part 1 Dose Level 1 - Active
Part 1 Dose Level 1 - Placebo
Part 1 Dose Level 2 - Active
Part 1 Dose Level 2 - Placebo
Part 2 Multi-Dose Level 1 - Active
Part 2 Multi-Dose Level 1 - Placebo
Part 2 Multi-Dose Level 2 - Active
Part 2 Multi-Dose Level 2 - Placebo
Arm Description
Outcomes
Primary Outcome Measures
Treatment emergent adverse events - Part 1
TEAEs in subjects receiving NGM621 compared to placebo
Treatment emergent adverse events - Part 2
TEAEs in subjects receiving NGM621 compared to placebo
Clinical status at Day 15 and Day 29 - Part 2
Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
Secondary Outcome Measures
Maxiumum Serum Concentration [Cmax]
Mortality at Day 29
Duration of Supplemental Oxygen Requirement
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Full Information
NCT ID
NCT04582318
First Posted
October 7, 2020
Last Updated
February 8, 2022
Sponsor
NGM Biopharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04582318
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the rapidly changing therapeutic landscape in the COVID-19 space and an assessment of unmet medical need, Part 2 of the study was cancelled (per protocol Section 4.3). Meanwhile, Part 1 of the study was completed.
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
March 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 Dose Level 1 - Active
Arm Type
Experimental
Arm Title
Part 1 Dose Level 1 - Placebo
Arm Type
Placebo Comparator
Arm Title
Part 1 Dose Level 2 - Active
Arm Type
Experimental
Arm Title
Part 1 Dose Level 2 - Placebo
Arm Type
Placebo Comparator
Arm Title
Part 2 Multi-Dose Level 1 - Active
Arm Type
Active Comparator
Arm Title
Part 2 Multi-Dose Level 1 - Placebo
Arm Type
Placebo Comparator
Arm Title
Part 2 Multi-Dose Level 2 - Active
Arm Type
Active Comparator
Arm Title
Part 2 Multi-Dose Level 2 - Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 will be administered via IV infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered via IV infusion
Primary Outcome Measure Information:
Title
Treatment emergent adverse events - Part 1
Description
TEAEs in subjects receiving NGM621 compared to placebo
Time Frame
85 days
Title
Treatment emergent adverse events - Part 2
Description
TEAEs in subjects receiving NGM621 compared to placebo
Time Frame
91 days
Title
Clinical status at Day 15 and Day 29 - Part 2
Description
Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Maxiumum Serum Concentration [Cmax]
Time Frame
91 days
Title
Mortality at Day 29
Time Frame
29 days
Title
Duration of Supplemental Oxygen Requirement
Time Frame
91 days
Title
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Time Frame
91 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
NGM Clinical Study Site
City
Brisbane
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
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
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