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Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19

NCT05293678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-02-23

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).

The secondary objectives of the study are:

* To assess the concentration-time profile of REGN15160 in serum
* To assess the immunogenicity of REGN15160

Conditions

  • Healthy

Interventions

DRUG

REGN15160 (IV)

Administered in single intravenous (IV) dose

DRUG

Matching Placebo (IV)

Administered in single IV dose

DRUG

REGN15160 (SC)

Administered in single subcutaneous (SC) dose

DRUG

Matching Placebo (SC)

Administered in single SC dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2023-01-26
Completion
2023-01-26

Countries

  • Belgium

Study Locations

More Related Trials

Entities

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 NCT05293678 on ClinicalTrials.gov