drugset / Trial / NCT06444178

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants

NCT06444178

Phase 1 Completed 224 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments"). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines. The aim of the study is to see if aspirin alone or the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Timeline

Start
2024-09-30
Primary completion
2025-04-07
Completion
2025-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule Oral
Subject REGN7508 Monoclonal antibody Intravenous
Subject REGN9933 Monoclonal antibody Intravenous
Comparator Rivaroxaban Other / unclassified Oral

Indications

No indication recorded.