Evaluation of IGM-6268 in Healthy Volunteers

IGM Biosciences

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: IGM-6268

Study type: Interventional

Funder types: Industry

Identifiers

NCT05160402

IGM-6268-001

Details and patient eligibility

About

This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple ascending (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once (SAD), or once or twice each day for 5 days (MAD).

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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, physical examination, 12-lead electrocardiogram, laboratory assessments, and vital signs at screening.
• For women of childbearing potential or men, agreement to use at least one highly effective form of non-hormonal contraception or one highly effective form and one effective form of non-hormonal contraception through the course of study treatment and for 3 months after the last dose of IGM-6268.
• Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.

Exclusion criteria

• Receipt of any COVID-19 vaccine or contemplating receipt of any COVID-19 vaccine (or participating in a COVID-19 vaccine trial) during this study and follow-up periods (approximately 65 days from enrollment). Subjects are permitted to withdraw at any time if they decide to receive the vaccine
• History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT), or positive SARS-CoV-2 serology test, at any time before enrollment.
• Confirmed or suspected pulmonary or systemic bacterial infection.
• Current or planned participation in any interventional clinical trial during the study and follow-up periods.
• History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Uncontrolled human immunodeficiency virus (HIV) infection.
• Nasal polyps (history or physical exam) or any structural abnormality of nose that, in the opinion of the investigator, could compromise administration or receipt of study drug (e.g., nasal septal deviation).
• History of reactive airway disease or hypersensitivity to any component of study drug or placebo.
• Use of any nasally-administered drug between 5 days prior to study enrollment and 2 days after receipt of last dose administered.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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54 participants in 6 patient groups

Cohort 1 (SAD)

Experimental group

Description:

In Cohort 1, subjects will be randomized to receive a single intranasal and intraoral administration of 1 mg of IGM 6268 or placebo

Treatment:

Drug: IGM-6268

Drug: Placebo

Cohort 2 (SAD)

Experimental group

Description:

In Cohort 2, subjects will be randomized to receive a single intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo

Treatment:

Drug: IGM-6268

Drug: Placebo

Cohort 3 (SAD)

Experimental group

Description:

In Cohort 3, subjects will be randomized to receive a single intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo

Treatment:

Drug: IGM-6268

Drug: Placebo

Cohort 4 (MAD)

Experimental group

Description:

In Cohort 4, subjects will be randomized to receive a single intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once a day for 5 days.

Treatment:

Drug: IGM-6268

Drug: Placebo

Cohort 5 (MAD)

Experimental group

Description:

In Cohort 5, subjects will be randomized to receive a single intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once a day for 5 days.

Treatment:

Drug: IGM-6268

Drug: Placebo

Cohort 6 (MAD)

Experimental group

Description:

In Cohort 6, subjects will be randomized to receive a single intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice a day for 5 days.

Treatment:

Drug: IGM-6268

Drug: Placebo