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Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults

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Contents

clinicaltrials.gov/study/NCT06665828
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT066658280
Trial Recruitment Size
560
Trial Sponsor
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
0
Clinical Trial Start Date
February 22, 2025
0
Primary Completion Date
December 12, 2025
0
Study Completion Date
December 12, 2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 10
Official Name
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN9533, a Monoclonal Antibody Against Factor XII, in Healthy Adults0
Last Updated
October 30, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Outcomes Assessor0
Care Provider0
Participant0

Other attributes

Intervention Treatment
Matching Placebo0
REGN95330
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

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