Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05184218
Status:
TERMINATED
Last Update Posted:
2022-10-14
First Post:
2022-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721989', 'term': 'IGM-6268'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Subjects will be randomized to receive intranasal and intraoral administration of IGM-6268 or placebo at the assigned doses. Cohorts will be enrolled sequentially. Cohorts 1-3 and Sentinel will enroll healthy volunteers and Cohorts 4-5 and Ph1b Expansion will enroll mild-moderate COVID-19 patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0', 'timeFrame': 'Through 60 days following receipt of final dose'}], 'secondaryOutcomes': [{'measure': 'Concentration of IGM-6268 in serum', 'timeFrame': 'Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)'}, {'measure': 'Incidence of anti-IGM-6268 antibodies in serum', 'timeFrame': 'Prior to dosing and at Day 28 following receipt of initial dose'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.', 'detailedDescription': 'IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.\n\nIGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Volunteers\n\nInclusion Criteria:\n\n* Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age\n* Has a body mass index (BMI) \\< 35 kg/m2.\n* Is healthy as determined by medical history and physical examination\n* Agrees to use contraception through 3 months after the last dose of IGM-6268\n\nExclusion Criteria:\n\n* Receipt of any COVID-19 vaccine during this study and follow-up period\n* Prior positive SARS-CoV2 test\n* Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection\n* Use of any nasally administered drug\n\nMild-Moderate COVID Patients\n\nInclusion Criteria:\n\n* Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age\n* Agrees to use contraception through 3 months after the last dose of IGM-6268\n* Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.\n* Signs and symptoms of mild to moderate COVID-19 but not requiring hospitalization\n* Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-authorized antigen or NAAT diagnostic assay during the period of 72 hours prior to enrollment.\n\nExclusion Criteria:\n\n* Receipt of any COVID-19 vaccine during this study and follow-up period\n* Receipt of remdisivir, antiviral antibody treatment (plasma or Mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs\n* Concurrent use of drugs not approved for use in COVID-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide).\n* Co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (Type 1 or 2), chronic kidney disease, or asthma\n* Subject is considered to be in their last few weeks of life prior to this acute illness\n* Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma\n* Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection\n* Influenza or confirmed or suspected pulmonary or systemic bacterial infection\n* Receipt of any COVID-19 vaccine during this study and follow-up period\n* Use of any nasally administered drug'}, 'identificationModule': {'nctId': 'NCT05184218', 'briefTitle': 'Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'IGM Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19', 'orgStudyIdInfo': {'id': 'IGM-6268-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sentinel', 'description': 'In the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'In Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'In Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'In Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'In Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'In Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.', 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ph1b Expansion', 'description': "In the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity.", 'interventionNames': ['Drug: IGM-6268', 'Drug: Placebo']}], 'interventions': [{'name': 'IGM-6268', 'type': 'DRUG', 'description': 'Active Comparator', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Ph1b Expansion', 'Sentinel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Ph1b Expansion', 'Sentinel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Farmovs', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}], 'overallOfficials': [{'name': 'Roel Funke', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IGM Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IGM Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}