CompletedPhase 1

A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

Belgium40 participantsStarted 2023-11-28

Plain-language summary

The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people. Other aims are to assess: * How much of the study drug is in the blood at different times * Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

Who can participate

Age range

18 Years – 60 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 SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol
. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
. Has a body mass index (BMI) between 18 and 31 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, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug

Exclusion criteria

. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol

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

Occurrence of all treatment emergent adverse events (TEAEs)

Timeframe: Through approximately day 365

Severity of all TEAEs

Timeframe: Through approximately day 365

Occurrence of all treatment emergent serious adverse events (TE-SAEs)

Timeframe: Through approximately day 365

Severity of all TE-SAEs

Timeframe: Through approximately day 365

Trial details

NCT IDNCT05923424

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-04

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range

18 Years – 60 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 SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol
. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
. Has a body mass index (BMI) between 18 and 31 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, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug

Exclusion criteria

. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol

What they're measuring

Occurrence of all treatment emergent adverse events (TEAEs)

Timeframe: Through approximately day 365

Severity of all TEAEs

Timeframe: Through approximately day 365

Occurrence of all treatment emergent serious adverse events (TE-SAEs)

Timeframe: Through approximately day 365

Severity of all TE-SAEs

Timeframe: Through approximately day 365