Evaluation of IGM-6268 in Healthy Volunteers

NCT ID: NCT05160402

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2022-08-18

Brief Summary

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).

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 (SAD)

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

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Cohort 2 (SAD)

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

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Cohort 3 (SAD)

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

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Cohort 4 (MAD)

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.

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Cohort 5 (MAD)

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.

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Cohort 6 (MAD)

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.

Group Type: EXPERIMENTAL

IGM-6268

Intervention Type: DRUG

Active comparator

Placebo

Intervention Type: DRUG

Placebo comparator

Interventions

IGM-6268

Active comparator

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IGM Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roel Funke

Role: STUDY_DIRECTOR

IGM Biosciences, Inc.

Locations

Aventiv Research

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IGM-6268-001

Identifier Type: -

Identifier Source: org_study_id