Clinical trial NCT05181683: COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Official title: A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Chronic Stable Illness
Keywords: Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Targeted grade ≥3 treatment-emergent adverse events (TEAEs)
timeFrame: Through end of study, approximately 16 weeks
measure: Grade ≥3 injection-site reactions (ISRs)
timeFrame: Through end of study, approximately 16 weeks
measure: Grade ≥2 infusion-related reactions (IRRs)
timeFrame: Through end of study, approximately 16 weeks
measure: Grade ≥2 hypersensitivity reactions
timeFrame: Through end of study, approximately 16 weeks
measure: Serious adverse events (SAEs)
timeFrame: Through end of study, approximately 16 weeks
Secondary outcomes:
measure: Concentrations of casirivimab and imdevimab in serum over time
timeFrame: Up to 16 weeks
measure: Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab
timeFrame: Up to 16 weeks
measure: Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Winter Park
country: United States
facility: Regeneron StudySite
state: Florida
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: