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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Chronic Stable Illness

Treatments

Drug: Placebo

Drug: REGN10933+REGN10987

Study type

Interventional

Funder types

Industry

Identifiers

R10933-10987-HV-2093

Details and patient eligibility

About

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

Enrollment

974 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 Exclusion Criteria:

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