Overview
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-05-19
2022-05-19
Target enrollment:
0
0
Participant gender:
All
All
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 timePhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Regeneron Pharmaceuticals
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/ Exclusion Criteria apply