Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
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
Sponsor: IGM Biosciences, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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 Endpoints
Concentration of IGM-6268 in serum
Incidence of anti-IGM-6268 antibodies in serum
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 infect…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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