Study 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.
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
1 other identifier
interventional
16
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2021
CompletedFebruary 25, 2022
February 1, 2022
3 months
October 7, 2020
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Study Arms (8)
Part 1 Dose Level 1 - Active
EXPERIMENTALPart 1 Dose Level 1 - Placebo
PLACEBO COMPARATORPart 1 Dose Level 2 - Active
EXPERIMENTALPart 1 Dose Level 2 - Placebo
PLACEBO COMPARATORPart 2 Multi-Dose Level 1 - Active
ACTIVE COMPARATORPart 2 Multi-Dose Level 1 - Placebo
PLACEBO COMPARATORPart 2 Multi-Dose Level 2 - Active
ACTIVE COMPARATORPart 2 Multi-Dose Level 2 - Placebo
PLACEBO COMPARATORInterventions
NGM621 will be administered via IV infusion
Placebo will be administered via IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NGM Clinical Study Site
Brisbane, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 9, 2020
Study Start
November 9, 2020
Primary Completion
February 18, 2021
Study Completion
March 11, 2021
Last Updated
February 25, 2022
Record last verified: 2022-02