COVID-19, Healthy Volunteers
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGIGM-6268
Active Comparator
DRUGPlacebo
Placebo Comparator
Sponsors
IGM Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded study
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0 | Through 60 days following receipt of final dose |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of IGM-6268 in serum | Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients) |
| Incidence of anti-IGM-6268 antibodies in serum | Prior to dosing and at Day 28 following receipt of initial dose |
Countries
South Africa
Outcome results
None listed