Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
Healthy Volunteers, COVID-19
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility 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
Sites / Locations
- Farmovs
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Sentinel
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Ph1b Expansion
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.
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.
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.
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.
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.
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.
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.