Status:
COMPLETED
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy
Chronic Stable Illness
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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:...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
- Weighs between ≥60 kg and ≤100 kg at the time of screening
- 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
- Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization
- Key
Exclusion
- Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
- Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
- Prior use of casirivimab+imdevimab at any time prior to randomization
- 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)
- 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
- Body mass index (BMI) ≥28 kg/m2
- Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening
- Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
- Uncontrolled hypertension, in the opinion of the investigator
- 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
- Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
- Is pregnant at screening
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05181683
Start Date
January 7 2022
End Date
June 3 2022
Last Update
October 14 2025
Active Locations (2)
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1
Regeneron Study Site
Miami, Florida, United States, 33186
2
Regeneron StudySite
Winter Park, Florida, United States, 32789