COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181683
• Other study ID #: R10933-10987-COV-2179
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2022
• Est. completion date: June 3, 2022

Study information

• Verified date: June 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stable Illness
• COVID-19
• Healthy

Intervention

Drug:
• Casirivimab+Imdevimab
Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration

Locations

Country	Name	City	State
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron StudySite	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Targeted grade =3 treatment-emergent adverse events (TEAEs)		Through end of study, approximately 16 weeks
Primary	Grade =3 injection-site reactions (ISRs)		Through end of study, approximately 16 weeks
Primary	Grade =2 infusion-related reactions (IRRs)		Through end of study, approximately 16 weeks
Primary	Grade =2 hypersensitivity reactions		Through end of study, approximately 16 weeks
Primary	Serious adverse events (SAEs)		Through end of study, approximately 16 weeks
Secondary	Concentrations of casirivimab and imdevimab in serum over time		Up to 16 weeks
Secondary	Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab		Up to 16 weeks
Secondary	Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab		Up to 16 weeks