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 range18 Years – 60 Years

SexALL

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
✕. Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
✕. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
✕. Has history of alcohol or drug abuse as determined by the investigator
✕. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food

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 range18 Years – 60 Years

SexALL

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
✕. Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
✕. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
✕. Has history of alcohol or drug abuse as determined by the investigator
✕. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food

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