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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05184218
• Other study ID #: IGM-6268-002
• Status: Terminated
• Phase: Phase 1
• Start date: January 20, 2022
• Est. completion date: July 4, 2022

Study information

• Verified date: October 2022
• Source: IGM Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 4, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
South Africa	Farmovs	Bloemfontein	Free State

Sponsors (1)

Lead Sponsor	Collaborator
IGM Biosciences, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

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