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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06444178
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Aspirin — DRUG
    Oral administration
  • REGN9933 — DRUG
    Administered intravenous (IV)
  • REGN7508 — DRUG
    Administered IV
  • Rivaroxaban — DRUG
    Oral administration

Study Details

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)

Key Dates

Start date
Sep 30, 2024
Status verified
Jul 2025
Primary completion
Apr 7, 2025
Completion
Jul 9, 2025

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Aspirin
    Randomized 1:1:1:1
  • Experimental: Arm 2: Aspirin + REGN9933
    Randomized 1:1:1:1
  • Experimental: Arm 3: Aspirin + REGN7508
    Randomized 1:1:1:1
  • Active Comparator: Arm 4: Aspirin + Rivaroxaban
    Randomized 1:1:1:1

Primary Outcome Measure

Change in fecal hemoglobin content (FHC) [ Time Frame: Baseline and up to day 22 ]

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