SARS-CoV-2 InfectionPhase 1/2NCT04582318
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 Phase 1/2 study testing NGM621 in people with SARS-CoV-2 Infection, run by NGM Biopharmaceuticals, Inc at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- NGM621
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Nov 2020to 11 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- SARS-CoV-2 Infection
- Being tested
- NGM621, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM621Biological
NGM621 will be administered via IV infusion
PlaceboBiological
Placebo will be administered via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Level 1 - Active | Experimental | Not described Receives: Biological: NGM621 |
| Part 1 Dose Level 1 - Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Part 1 Dose Level 2 - Active | Experimental | Not described Receives: Biological: NGM621 |
| Part 1 Dose Level 2 - Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Part 2 Multi-Dose Level 1 - Active | Active comparator | Not described Receives: Biological: NGM621 |
| Part 2 Multi-Dose Level 1 - Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Part 2 Multi-Dose Level 2 - Active | Active comparator | Not described Receives: Biological: NGM621 |
| Part 2 Multi-Dose Level 2 - Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events - Part 1
TEAEs in subjects receiving NGM621 compared to placebo
Measured: 85 days
Treatment emergent adverse events - Part 2
TEAEs in subjects receiving NGM621 compared to placebo
Measured: 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
Measured: 29 days
Secondary outcomes (4)
Maxiumum Serum Concentration [Cmax]
Measured: 91 days
Mortality at Day 29
Measured: 29 days
Duration of Supplemental Oxygen Requirement
Measured: 91 days
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start9 Nov 2020
- Primary completion18 Feb 2021
- Study completion11 Mar 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582318
- Sponsor's protocol ID
- 621-CP-102
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04582318
- Acronym / sponsor ID
- 621-CP-102
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Level 1 - Active | Experimental | Biological: NGM621 |
| Part 1 Dose Level 1 - Placebo | Placebo comparator | Biological: Placebo |
| Part 1 Dose Level 2 - Active | Experimental | Biological: NGM621 |
| Part 1 Dose Level 2 - Placebo | Placebo comparator | Biological: Placebo |
| Part 2 Multi-Dose Level 1 - Active | Active comparator | Biological: NGM621 |
| Part 2 Multi-Dose Level 1 - Placebo | Placebo comparator | Biological: Placebo |
| Part 2 Multi-Dose Level 2 - Active | Active comparator | Biological: NGM621 |
| Part 2 Multi-Dose Level 2 - Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGM621NGM621 will be administered via IV infusion | Biological | Part 1 Dose Level 1 - Active, Part 1 Dose Level 2 - Active, Part 2 Multi-Dose Level 1 - Active, Part 2 Multi-Dose Level 2 - Active |
| PlaceboPlacebo will be administered via IV infusion | Biological | Part 1 Dose Level 1 - Placebo, Part 1 Dose Level 2 - Placebo, Part 2 Multi-Dose Level 1 - Placebo, Part 2 Multi-Dose Level 2 - Placebo |
Primary outcome
Treatment emergent adverse events - Part 1
Time frame: 85 days
TEAEs in subjects receiving NGM621 compared to placebo
Treatment emergent adverse events - Part 2
Time frame: 91 days
TEAEs in subjects receiving NGM621 compared to placebo
Clinical status at Day 15 and Day 29 - Part 2
Time frame: 29 days
Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
4 secondary outcomes
Maxiumum Serum Concentration [Cmax]
Time frame: 91 days
Mortality at Day 29
Time frame: 29 days
Duration of Supplemental Oxygen Requirement
Time frame: 91 days
Change in Hemolytic Assays (CH50 and AH50) from Baseline
Time frame: 91 days
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NGM621 in people with SARS-CoV-2 Infection, run by NGM Biopharmaceuticals, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events - Part 1 (time frame: 85 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.