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

Phase 1TerminatedNCT05184218

IGM Biosciences, Inc.26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers COVID-19

Interventions

IGM-6268DRUG

Active Comparator

PlaceboDRUG

Placebo Comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Farmovs

Bloemfontein, Free State, South Africa

Outcomes

Primary Outcomes

Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0

Time frame: Through 60 days following receipt of final dose

Secondary Outcomes

Concentration of IGM-6268 in serum

Time frame: Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)

Incidence of anti-IGM-6268 antibodies in serum

Time frame: Prior to dosing and at Day 28 following receipt of initial dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.