Chronic Stable Illness, Healthy
Conditions
Keywords
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
Brief summary
The primary objectives are: * To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: * To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo * To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration * To assess the immunogenicity of REGN10933 and REGN10987
Interventions
DRUGREGN10933+REGN10987
Administered subcutaneous (SC) every 4 weeks (Q4W)
DRUGPlacebo
Administered subcutaneous (SC) every 4 weeks (Q4W)
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study 2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening 3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission Key
Exclusion criteria
1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization 2. Subject-reported clinical history of COVID-19 as determined by investigator 3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection 4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19 5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening 6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening 7. Received investigational or approved SARS-CoV-2 vaccine 8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol 9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening NOTE: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Baseline |
| Concentrations of REGN10933 in serum over time | Up to 52 weeks |
| Concentrations of REGN10987 in serum over time | Up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve or exceed target concentration in serum of REGN10987 | Up to 52 weeks |
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to 52 weeks |
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 | Up to 52 weeks |
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 | Up to 52 weeks |
| Severity of TEAEs | Up to 52 weeks |
| Proportion of participants who achieve or exceed target concentration in serum of REGN10933 | Up to 52 weeks |
Countries
United States
Outcome results
None listed