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Evaluation of IGM-6268 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT05160402
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
IGM Biosciences, Inc.

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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: IGM-6268 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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.
Masking: Double (Participant, Investigator)
Masking Description: Cohorts 1-6 will receive IGM-6268 or placebo. Subjects and Investigators will be blinded.
Primary Purpose: Other
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Volunteers
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : April 30, 2022

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: IGM-6268
Active comparator

Drug: Placebo
Placebo 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: IGM-6268
Active comparator

Drug: Placebo
Placebo 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: IGM-6268
Active comparator

Drug: Placebo
Placebo 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: IGM-6268
Active comparator

Drug: Placebo
Placebo 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: IGM-6268
Active comparator

Drug: Placebo
Placebo 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: IGM-6268
Active comparator

Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. 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 Measures :
  1. IGM-6268 in serum [ Time Frame: Predose through Day 3 (SAD) or Day 6 (MAD) ]
  2. Incidence of anti-IGM-6268 antibodies in serum [ Time Frame: Prior to dosing and at Day 28 following receipt of initial dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160402


Contacts
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Contact: Iris Sison 510-329-9857 clinicaltrials@igmbio.com
Contact: Melanie Caruano 408-838-2308 clinicaltrials@igmbio.com

Locations
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United States, Ohio
Aventiv Research Recruiting
Columbus, Ohio, United States, 43213
Contact: Samir Arora, MD         
Sponsors and Collaborators
IGM Biosciences, Inc.
Investigators
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Study Director: Roel Funke IGM Biosciences, Inc.
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Responsible Party: IGM Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05160402    
Other Study ID Numbers: IGM-6268-001
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No