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

Primary Purpose

Healthy Volunteers, COVID-19

Status
Terminated
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
IGM-6268
Placebo
Sponsored by
IGM Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma
  • Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
  • Influenza or confirmed or suspected pulmonary or systemic bacterial infection
  • Receipt of any COVID-19 vaccine during this study and follow-up period
  • Use of any nasally administered drug

Sites / Locations

  • Farmovs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sentinel

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Ph1b Expansion

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0

Secondary Outcome Measures

Concentration of IGM-6268 in serum
Incidence of anti-IGM-6268 antibodies in serum

Full Information

First Posted
January 6, 2022
Last Updated
October 12, 2022
Sponsor
IGM Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05184218
Brief Title
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
Official Title
A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
July 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IGM Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
Double-blinded study
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sentinel
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Ph1b Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IGM-6268
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
Time Frame
Through 60 days following receipt of final dose
Secondary Outcome Measure Information:
Title
Concentration of IGM-6268 in serum
Time Frame
Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)
Title
Incidence of anti-IGM-6268 antibodies in serum
Time Frame
Prior to dosing and at Day 28 following receipt of initial dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 and physical examination Agrees to use contraception through 3 months after the last dose of IGM-6268 Exclusion Criteria: 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 Inclusion Criteria: 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. Exclusion Criteria: 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 Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection Influenza or confirmed or suspected pulmonary or systemic bacterial infection Receipt of any COVID-19 vaccine during this study and follow-up period Use of any nasally administered drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roel Funke
Organizational Affiliation
IGM Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Farmovs
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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