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

NCT05184218 | Terminated Phase 1 DMC

• 1 other identifier: IGM-6268-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; COVID-19

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)

• Concentration of IGM-6268 in serum

  Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)

• Incidence of anti-IGM-6268 antibodies in serum

  Prior to dosing and at Day 28 following receipt of initial dose

Study Arms (7)

Sentinel

EXPERIMENTAL

In the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Cohort 1

EXPERIMENTAL

In Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Cohort 2

EXPERIMENTAL

In Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Cohort 3

EXPERIMENTAL

In Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Cohort 4

EXPERIMENTAL

In Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Cohort 5

EXPERIMENTAL

In Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.

Drug: IGM-6268; Drug: Placebo

Ph1b Expansion

EXPERIMENTAL

In the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity.

Drug: IGM-6268; Drug: Placebo

Interventions

IGM-6268 DRUG

Active Comparator

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Ph1b Expansion; Sentinel

Placebo DRUG

Placebo Comparator

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Ph1b Expansion; Sentinel

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 and physical examination
• Agrees to use contraception through 3 months after the last dose of IGM-6268

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (1)

Farmovs

Bloemfontein, Free State, 9301, South Africa

Location

MeSH Terms

Conditions

COVID-19

Interventions

IGM-6268

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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: Double-blinded study
• Purpose: TREATMENT
• 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. Cohorts 1-3 and Sentinel will enroll healthy volunteers and Cohorts 4-5 and Ph1b Expansion will enroll mild-moderate COVID-19 patients.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 11, 2022
• Study Start: January 20, 2022
• Primary Completion: May 6, 2022
• Study Completion: July 4, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

ZA (1)