Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
- Registration Number
- NCT05184218
- Lead Sponsor
- IGM Biosciences, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sentinel IGM-6268 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. Sentinel Placebo 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. Cohort 1 IGM-6268 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. Cohort 1 Placebo 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. Cohort 2 IGM-6268 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. Cohort 2 Placebo 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. Cohort 3 Placebo 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. Cohort 5 Placebo 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. Ph1b Expansion IGM-6268 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. Ph1b Expansion Placebo 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. Cohort 4 Placebo 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. Cohort 5 IGM-6268 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. Cohort 3 IGM-6268 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. Cohort 4 IGM-6268 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Farmovs
🇿🇦Bloemfontein, Free State, South Africa