Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519437
• Other study ID #: R10933-10987-HV-2093
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2020
• Est. completion date: November 22, 2021

Study information

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

Clinical Trial Summary

The primary objectives are: - To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo - To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: - To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo - To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration - To assess the immunogenicity of REGN10933 and REGN10987

Recruitment information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Key Inclusion Criteria:

1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study

2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening

3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

Key Exclusion Criteria:

1. Positive diagnostic test for SARS-CoV-2 infection =72 hours prior to randomization

2. Subject-reported clinical history of COVID-19 as determined by investigator

3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection

4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19

5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening

6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening

7. Received investigational or approved SARS-CoV-2 vaccine

8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol

9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

Related Conditions & MeSH terms

• Chronic Stable Illness
• COVID-19
• Healthy

Intervention

Drug:
• REGN10933+REGN10987
Administered subcutaneous (SC) every 4 weeks (Q4W)
• Placebo
Administered subcutaneous (SC) every 4 weeks (Q4W)

Locations

Country	Name	City	State
United States	Regeneron Study Site	Austin	Texas
United States	Regeneron Study Site	Dayton	Ohio
United States	Regeneron Study Site	Lincoln	Nebraska
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	Rogers	Arkansas
United States	Regeneron Study Site	Sacramento	California
United States	Regeneron Study Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Baseline
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Day 29
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Day 57
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Day 85
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Day 113
Primary	Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration		Within 4 days postdose at Day 141
Primary	Concentrations of REGN10933 in serum over time		Up to 52 weeks
Primary	Concentrations of REGN10987 in serum over time		Up to 52 weeks
Secondary	Proportion of participants with treatment-emergent adverse events (TEAEs)		Up to 52 weeks
Secondary	Severity of TEAEs		Up to 52 weeks
Secondary	Proportion of participants who achieve or exceed target concentration in serum of REGN10933		Up to 52 weeks
Secondary	Proportion of participants who achieve or exceed target concentration in serum of REGN10987		Up to 52 weeks
Secondary	Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933		Up to 52 weeks
Secondary	Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987		Up to 52 weeks