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

A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: IGM-6268

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • FARMOVS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sentinel; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Cohort 1; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Cohort 2; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Cohort 3; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Cohort 4; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Cohort 5; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator
EXPERIMENTAL: Ph1b Expansion; 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.	Drug: Placebo; Placebo Comparator; Drug: IGM-6268; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Incidence of anti-IGM-6268 antibodies in serum	Prior to dosing and at Day 28 following receipt of initial dose
Concentration of IGM-6268 in serum	Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)

Collaborators and Investigators

• Sponsor: IGM Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2022
• Primary Completion (ACTUAL): May 6, 2022
• Study Completion (ACTUAL): July 4, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (ACTUAL): January 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IGM-6268-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes