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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04582318




Registration number
NCT04582318
Ethics application status
Date submitted
7/10/2020
Date registered
9/10/2020

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
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
Secondary ID [1] 0 0
621-CP-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NGM621
Treatment: Other - 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 -


Treatment: Other: NGM621
NGM621 will be administered via IV infusion

Treatment: Other: Placebo
Placebo will be administered via IV infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events - Part 1
Timepoint [1] 0 0
85 days
Primary outcome [2] 0 0
Treatment emergent adverse events - Part 2
Timepoint [2] 0 0
91 days
Primary outcome [3] 0 0
Clinical status at Day 15 and Day 29 - Part 2
Timepoint [3] 0 0
29 days
Secondary outcome [1] 0 0
Maxiumum Serum Concentration [Cmax]
Timepoint [1] 0 0
91 days
Secondary outcome [2] 0 0
Mortality at Day 29
Timepoint [2] 0 0
29 days
Secondary outcome [3] 0 0
Duration of Supplemental Oxygen Requirement
Timepoint [3] 0 0
91 days
Secondary outcome [4] 0 0
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Timepoint [4] 0 0
91 days

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2021
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
NGM Clinical Study Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04582318