Evaluation of IGM-6268 in Healthy Volunteers

NCT05160402 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IGM-6268-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (6)

Cohort 1 (SAD)

EXPERIMENTAL

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

Drug: IGM-6268; Drug: Placebo

Cohort 2 (SAD)

EXPERIMENTAL

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: IGM-6268; Drug: Placebo

Cohort 3 (SAD)

EXPERIMENTAL

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: IGM-6268; Drug: Placebo

Cohort 4 (MAD)

EXPERIMENTAL

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: IGM-6268; Drug: Placebo

Cohort 5 (MAD)

EXPERIMENTAL

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: IGM-6268; Drug: Placebo

Cohort 6 (MAD)

EXPERIMENTAL

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: IGM-6268; Drug: Placebo

Interventions

IGM-6268 DRUG

Active comparator

Cohort 1 (SAD); Cohort 2 (SAD); Cohort 3 (SAD); Cohort 4 (MAD); Cohort 5 (MAD); Cohort 6 (MAD)

Placebo DRUG

Placebo comparator

Cohort 1 (SAD); Cohort 2 (SAD); Cohort 3 (SAD); Cohort 4 (MAD); Cohort 5 (MAD); Cohort 6 (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (1)

Aventiv Research

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Interventions

IGM-6268

Study Officials

• Roel Funke

  IGM Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohorts 1-6 will receive IGM-6268 or placebo. Subjects and Investigators will be blinded.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive intranasal and intraoral administration of IGM-6268 or placebo at the assigned doses. Cohorts will be enrolled sequentially.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 16, 2021
• Study Start: December 7, 2021
• Primary Completion: June 15, 2022
• Study Completion: August 18, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

US (1)