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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04582318
Registration number
NCT04582318
Ethics application status
Date submitted
7/10/2020
Date registered
9/10/2020
Date last updated
25/02/2022
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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621-CP-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NGM621
Other interventions - Placebo
Experimental: Part 1 Dose Level 1 - Active -
Placebo Comparator: Part 1 Dose Level 1 - Placebo -
Experimental: Part 1 Dose Level 2 - Active -
Placebo Comparator: Part 1 Dose Level 2 - Placebo -
Active Comparator: Part 2 Multi-Dose Level 1 - Active -
Placebo Comparator: Part 2 Multi-Dose Level 1 - Placebo -
Active Comparator: Part 2 Multi-Dose Level 2 - Active -
Placebo Comparator: Part 2 Multi-Dose Level 2 - Placebo -
Other interventions: NGM621
NGM621 will be administered via IV infusion
Other interventions: Placebo
Placebo will be administered via IV infusion
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment emergent adverse events - Part 1
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Assessment method [1]
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TEAEs in subjects receiving NGM621 compared to placebo
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Timepoint [1]
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85 days
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Primary outcome [2]
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Treatment emergent adverse events - Part 2
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Assessment method [2]
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TEAEs in subjects receiving NGM621 compared to placebo
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Timepoint [2]
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91 days
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Primary outcome [3]
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Clinical status at Day 15 and Day 29 - Part 2
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Assessment method [3]
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Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
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Timepoint [3]
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29 days
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Secondary outcome [1]
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Maxiumum Serum Concentration [Cmax]
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Assessment method [1]
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0
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Timepoint [1]
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91 days
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Secondary outcome [2]
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Mortality at Day 29
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Assessment method [2]
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0
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Timepoint [2]
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29 days
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Secondary outcome [3]
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Duration of Supplemental Oxygen Requirement
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Assessment method [3]
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0
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Timepoint [3]
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91 days
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Secondary outcome [4]
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Change in Hemolytic Assays (CH50 and AH50) from Baseline
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Assessment method [4]
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0
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Timepoint [4]
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91 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/03/2021
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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NGM Clinical Study Site - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
NGM Biopharmaceuticals, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04582318
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04582318
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