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OpenTrials
Completed

NCT Number: NCT05923424

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

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)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven Gasthuisberg Campus

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

NOTE: Other protocol defined inclusion / exclusion criteria apply

Treatment and study plan

REGN17092

Drug

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Drug

Single ascending IV or SC administration per the protocol

Primary outcomes

  1. Occurrence of all treatment emergent adverse events (TEAEs)

    Time frame: Through approximately day 365

  2. Severity of all TEAEs

    Time frame: Through approximately day 365

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

    Time frame: Through approximately day 365

  4. Severity of all TE-SAEs

    Time frame: Through approximately day 365

Secondary outcomes

  1. Concentrations of REGN17092 in serum over time

    Time frame: Through approximately day 365

  2. Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time

    Time frame: Through approximately day 365

  3. Titer of ADAs to REGN17092 over time

    Time frame: Through approximately day 365

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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