Status:
TERMINATED
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
Lead Sponsor:
IGM Biosciences, Inc.
Conditions:
Healthy Volunteers
COVID-19
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 intraorall...
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 bin...
Eligibility Criteria
Inclusion
- Healthy Volunteers
- 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
- 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.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05184218
Start Date
January 20 2022
End Date
July 4 2022
Last Update
October 14 2022
Active Locations (1)
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1
Farmovs
Bloemfontein, Free State, South Africa, 9301