Clinical trial NCT05184218: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
COVID-19
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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. Cohorts 1-3 and Sentinel will enroll healthy volunteers and Cohorts 4-5 and Ph1b Expansion will enroll mild-moderate COVID-19 patients.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
timeFrame: Through 60 days following receipt of final dose
Secondary outcomes:
measure: Concentration of IGM-6268 in serum
timeFrame: Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)
measure: Incidence of anti-IGM-6268 antibodies in serum
timeFrame: Prior to dosing and at Day 28 following receipt of initial dose
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Farmovs
state: Free State
Study officials:
affiliation: IGM Biosciences, Inc.
name: Roel Funke
role: STUDY_DIRECTOR
References: