Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IGM Biosciences, Inc.

Criteria

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