A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05603195
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • REGN7508 (IV) — DRUG
    Administered sequential, ascending single intravenous (IV) dose
  • REGN7508 (SC) — DRUG
    Administered sequential, ascending single subcutaneous (SC) dose
  • Matching Placebo (IV) — DRUG
    Administered sequential, ascending single intravenous (IV) dose
  • Matching Placebo (SC) — DRUG
    Administered sequential, ascending single subcutaneous (SC) dose

Study Details

This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants. This 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
Jan 12, 2023
Status verified
Sep 2024
Primary completion
Sep 17, 2024
Completion
Sep 17, 2024

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Lowest IV Dose
    Randomized 3:1
  • Experimental: Cohort 2 Low IV Dose
    Randomized 3:1
  • Experimental: Cohort 3 Mid IV Dose
    Randomized 3:1
  • Experimental: Cohort 4 High IV Dose
    Randomized 3:1
  • Experimental: Cohort 5 Higher IV Dose
    Randomized 3:1
  • Experimental: Cohort 6 High SC Dose
    Randomized 3:1
  • Experimental: Cohort 7 Higher SC Dose
    Randomized 3:1
  • Experimental: Optional: Cohort 8 Highest IV or SC Dose
    Randomized 3:1
  • Experimental: Cohort 9 High SC Dose
    Randomized 3:1
  • Experimental: Optional: Cohort 10 Highest SC Dose
    Randomized 3:1

Primary Outcome Measure

Incidences of treatment-emergent adverse events (TEAE) [ Time Frame: Up to 36 days ]

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