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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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