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

IGM-6268-002

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.

2022-01-20

2022-05-06

2022-07-04

Terminated

Early phase I

26

Healthy Volunteers Inclusion Criteria: * Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age * Has a body mass index (BMI) \< 35 kg/m2. * Is healthy as determined by medical history and physical examination * Agrees to use contraception through 3 months after the last dose of IGM-6268 Exclusion Criteria: * Receipt of any COVID-19 vaccine during this study and follow-up period * Prior positive SARS-CoV2 test * Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection * Use of any nasally administered drug Mild-Moderate COVID Patients Inclusion Criteria: * Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age * Agrees to use contraception through 3 months after the last dose of IGM-6268 * Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol. * Signs and symptoms of mild to moderate COVID-19 but not requiring hospitalization * 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. Exclusion Criteria: * Receipt of any COVID-19 vaccine during this study and follow-up period * Receipt of remdisivir, antiviral antibody treatment (plasma or Mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs * Concurrent use of drugs not approved for use in COVID-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide). * Co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (Type 1 or 2), chronic kidney disease, or asthma * Subject is considered to be in their last few weeks of life prior to this acute illness * Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma * Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection * Influenza or confirmed or suspected pulmonary or systemic bacterial infection * Receipt of any COVID-19 vaccine during this study and follow-up period * Use of any nasally administered drug

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-blinded study', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2022-10-14