Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04582318
Status:
TERMINATED
Last Update Posted:
2022-02-25
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent adverse events - Part 1', 'timeFrame': '85 days', 'description': 'TEAEs in subjects receiving NGM621 compared to placebo'}, {'measure': 'Treatment emergent adverse events - Part 2', 'timeFrame': '91 days', 'description': 'TEAEs in subjects receiving NGM621 compared to placebo'}, {'measure': 'Clinical status at Day 15 and Day 29 - Part 2', 'timeFrame': '29 days', 'description': 'Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group'}], 'secondaryOutcomes': [{'measure': 'Maxiumum Serum Concentration [Cmax]', 'timeFrame': '91 days'}, {'measure': 'Mortality at Day 29', 'timeFrame': '29 days'}, {'measure': 'Duration of Supplemental Oxygen Requirement', 'timeFrame': '91 days'}, {'measure': 'Change in Hemolytic Assays (CH50 and AH50) from Baseline', 'timeFrame': '91 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Infection']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* BMI 18-32 kg/m2 inclusive\n* Ability to understand and provide informed consent\n* Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized\n* If on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation\n\nExclusion Criteria:\n\n* Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection\n* Known history of complement deficiency\n* 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.'}, 'identificationModule': {'nctId': 'NCT04582318', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'NGM Biopharmaceuticals, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '621-CP-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Level 1 - Active', 'interventionNames': ['Biological: NGM621']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Dose Level 1 - Placebo', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Level 2 - Active', 'interventionNames': ['Biological: NGM621']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Dose Level 2 - Placebo', 'interventionNames': ['Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 Multi-Dose Level 1 - Active', 'interventionNames': ['Biological: NGM621']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Multi-Dose Level 1 - Placebo', 'interventionNames': ['Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 Multi-Dose Level 2 - Active', 'interventionNames': ['Biological: NGM621']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Multi-Dose Level 2 - Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'NGM621', 'type': 'BIOLOGICAL', 'description': 'NGM621 will be administered via IV infusion', 'armGroupLabels': ['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']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo will be administered via IV infusion', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'NGM Clinical Study Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NGM Biopharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}