CompletedPhase 1

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

New Zealand56 participantsStarted 2023-12-06

Plain-language summary

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)

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Has a body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit
✓. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

What they're measuring

Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit

Timeframe: Baseline to day 113

Severity of TEAE's through the EOS visit

Timeframe: Baseline to day 113

Trial details

NCT IDNCT06137482

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-11

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