REGN-14256

Primary Objectives Phase 1 (Safety and Tolerability)
• Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions
Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7
Phase 1/2/3 (Clinical Efficacy)
• Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution
Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs)
Phase 2 and Phase 3 (Safety and Tolerability)
• Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs
Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity)
Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy
Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy
Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy