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

• ClinicalTrials.gov Identifier: NCT05184218
• Recruitment Status: Terminated
• First Posted: January 11, 2022
• Last Update Posted: October 14, 2022
• Sponsor: IGM Biosciences, Inc.
• Information provided by (Responsible Party): IGM Biosciences, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers; COVID-19	Drug: IGM-6268; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blinded study
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: January 20, 2022
• Actual Primary Completion Date: May 6, 2022
• Actual Study Completion Date: July 4, 2022

Arms and Interventions

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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo 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: IGM-6268; Active Comparator; Drug: Placebo; Placebo Comparator

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

South Africa

Farmovs

Bloemfontein, Free State, South Africa, 9301

Sponsors and Collaborators

IGM Biosciences, Inc.

Investigators

• Study Director: Roel Funke; IGM Biosciences, Inc.

More Information

• Responsible Party: IGM Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT05184218
• Other Study ID Numbers: IGM-6268-002
• First Posted: January 11, 2022
• Last Update Posted: October 14, 2022
• Last Verified: October 2022

• 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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases