Chronic Stable Illness, Healthy
Conditions
Keywords
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
Brief summary
The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to: * Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration * Characterize the immunogenicity of casirivimab and imdevimab in serum over time
Interventions
Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study 2. Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening 3. Weighs between ≥60 kg and ≤100 kg at the time of screening 4. Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards 5. Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization Key
Exclusion criteria
1. Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator 2. Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization 3. Prior use of casirivimab+imdevimab at any time prior to randomization 4. Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines) 5. Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening 6. Body mass index (BMI) ≥28 kg/m2 7. Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening 8. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening 9. Uncontrolled hypertension, in the opinion of the investigator 10. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening 11. Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ 12. Is pregnant at screening Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse events (SAEs) | Through end of study, approximately 16 weeks |
| Targeted grade ≥3 treatment-emergent adverse events (TEAEs) | Through end of study, approximately 16 weeks |
| Grade ≥2 infusion-related reactions (IRRs) | Through end of study, approximately 16 weeks |
| Grade ≥2 hypersensitivity reactions | Through end of study, approximately 16 weeks |
| Grade ≥3 injection-site reactions (ISRs) | Through end of study, approximately 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab | Up to 16 weeks |
| Concentrations of casirivimab and imdevimab in serum over time | Up to 16 weeks |
| Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab | Up to 16 weeks |
Countries
United States
Outcome results
None listed