Evaluation of IGM-6268 in Healthy Volunteers

A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Volunteers

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).

Study Overview

• Status: Terminated
• Conditions: 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): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Placebo; Placebo comparator; Drug: IGM-6268; Active comparator
Experimental: 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	Drug: Placebo; Placebo comparator; Drug: IGM-6268; Active comparator
Experimental: 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	Drug: Placebo; Placebo comparator; Drug: IGM-6268; Active comparator
Experimental: 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.	Drug: Placebo; Placebo comparator; Drug: IGM-6268; Active comparator
Experimental: 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.	Drug: Placebo; Placebo comparator; Drug: IGM-6268; Active comparator
Experimental: 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.	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
IGM-6268 in serum	Predose through Day 3 (SAD) or Day 6 (MAD)
Incidence of anti-IGM-6268 antibodies in serum	Prior to dosing and at Day 28 following receipt of initial dose

Collaborators and Investigators

• Sponsor: IGM Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

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

• Other Study ID Numbers: IGM-6268-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No