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Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults

NCT06665828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-06

No results posted yet for this study

Summary

The aim of this clinical trial is to see how safe and tolerable the clinical trial drug (REGN9533) is in healthy participants. This is the first time that REGN9533 will be given to humans.

After the clinical trial drug has been tested in healthy participants, future studies with REGN9533 will focus on participants with thromboembolic (blocking of blood vessels) diseases which include blood clots.

REGN9533 is a drug that is only used in clinical studies.

The clinical trial is looking at:

* The side effects REGN9533 might cause
* How much REGN9533 is in the blood at different times
* How the body reacts to REGN9533
* If the body makes antibodies to REGN9533 (unwanted immune response, which may cause REGN9533 to not work as well)
* What is the best dose of REGN9533

Conditions

  • Healthy Volunteer

Interventions

DRUG

REGN9533

Administered per the protocol

DRUG

Matching Placebo

Administered per the protocol.

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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2026-01-29
Completion
2026-01-29
FDA Drug
Yes

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 NCT06665828 on ClinicalTrials.gov