New antibody combo for COVID-19 passes early safety check
NCT ID NCT05181683
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested whether a combination of two antibodies (casirivimab and imdevimab) is safe and tolerable in healthy adults. Forty-five volunteers received the antibodies either as a shot under the skin or through an IV. The main goal was to check for side effects, not to treat or prevent COVID-19. The study is complete and helps guide future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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45 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
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Jun 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Regeneron Study Site
Miami, Florida, 33186, United States
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Regeneron StudySite
Winter Park, Florida, 32789, United States
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