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
- Conditions
- HealthyChronic Stable Illness
- Interventions
- Drug: Placebo
- Registration Number
- NCT04519437
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 974
- 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
- Stable medication for co-morbid condition(s) for at least 6 months prior to screening
- 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
- Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
- Subject-reported clinical history of COVID-19 as determined by investigator
- Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
- Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
- Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
- Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening
- Received investigational or approved SARS-CoV-2 vaccine
- Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REGN10933+REGN10987 REGN10933+REGN10987 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Concentrations of REGN10933 in serum over time Up to 52 weeks Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration Within 4 days postdose at Day 141 Concentrations of REGN10987 in serum over time Up to 52 weeks
- Secondary Outcome Measures
Name Time Method Proportion of participants with treatment-emergent adverse events (TEAEs) Up to 52 weeks Severity of TEAEs Up to 52 weeks Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 Up to 52 weeks Proportion of participants who achieve or exceed target concentration in serum of REGN10987 Up to 52 weeks Proportion of participants who achieve or exceed target concentration in serum of REGN10933 Up to 52 weeks Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 Up to 52 weeks
Trial Locations
- Locations (1)
Regeneron Study Site
🇺🇸Austin, Texas, United States