Sponsor Decision

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.

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.

IGM-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.

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

Double-blinded study