MedTrace Logo

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

NCT04519437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 974

Last updated 2022-01-26

No results posted yet for this study

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

Conditions

  • Healthy
  • Chronic Stable Illness

Interventions

DRUG

REGN10933+REGN10987

Administered subcutaneous (SC) every 4 weeks (Q4W)

DRUG

Placebo

Administered subcutaneous (SC) every 4 weeks (Q4W)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-26
Primary Completion
2021-11-22
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519437 on ClinicalTrials.gov