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
Overview
- Phase
- Phase 1
- Intervention
- IGM-6268
- Conditions
- Healthy Volunteers
- Sponsor
- IGM Biosciences, Inc.
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- •Has a body mass index (BMI) \< 35 kg/m
- •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
Arms & Interventions
Cohort 2
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.
Intervention: IGM-6268
Sentinel
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.
Intervention: IGM-6268
Sentinel
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.
Intervention: Placebo
Cohort 1
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.
Intervention: IGM-6268
Cohort 1
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.
Intervention: Placebo
Cohort 2
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.
Intervention: Placebo
Cohort 3
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.
Intervention: IGM-6268
Cohort 3
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.
Intervention: Placebo
Cohort 4
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.
Intervention: IGM-6268
Cohort 4
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.
Intervention: Placebo
Cohort 5
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.
Intervention: IGM-6268
Cohort 5
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.
Intervention: Placebo
Ph1b Expansion
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: IGM-6268
Ph1b Expansion
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: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- 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)