MedTrace Logo

Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers

NCT04616079 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-11-11

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants

The secondary objectives of the study are to:

* Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
* Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490

Conditions

  • Healthy Volunteer

Interventions

DRUG

REGN6490

Single dose of REGN6490

DRUG

Placebo

Placebo matching single dose of REGN6490

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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Belgium

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 NCT04616079 on ClinicalTrials.gov