A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06137482
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • REGN13335 — DRUG
    Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
  • Matching Placebo — DRUG
    Administered IV or SC, sequential ascending single dose

Study Details

This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. 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 present in the blood of study participants 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
Dec 6, 2023
Status verified
Mar 2025
Primary completion
Feb 11, 2025
Completion
Feb 11, 2025

Study Design

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

Arms

  • Experimental: IV Cohort 1 Low Dose
    Randomized as described in the protocol
  • Experimental: IV Cohort 2 Mid Dose
    Randomized as described in the protocol
  • Experimental: IV Cohort 3 High Dose
    Randomized as described in the protocol
  • Experimental: IV Cohort 4 Higher Dose
    Randomized as described in the protocol
  • Experimental: IV Cohort 5 Highest Dose
    Randomized as described in the protocol
  • Experimental: SC Cohort 1 Low Dose
    Randomized as described in the protocol
  • Experimental: SC Cohort 2 High Dose
    Randomized as described in the protocol
  • Experimental: IV or SC Optional Cohort
    ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit [ Time Frame: Baseline to day 113 ]

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