The purpose of this study is to learn about the safety and tolerability of differentdoses of REGN17092 administered with a needle either under the skin (called"subcutaneous") or into a vein (called an "infusion") in healthy participants. This isthe 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)
Not Provided
Drug: REGN17092
Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Drug: Matching Placebo
Single ascending IV or SC administration per the protocol
Key Inclusion Criteria:
1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to
randomization as described in the protocol
2. Has received complete primary series of standard-of-care COVID-19 vaccination per
local guidance, completed at least 2 weeks prior to screening
3. Has a body mass index (BMI) between 18 and 31 Kg/m^2 (inclusive) at the screening
visit
4. 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:
1. 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
2. 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
3. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening
visit
4. Has history of alcohol or drug abuse as determined by the investigator
5. 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
UZ Leuven Gasthuisberg Campus
Leuven, Belgium
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals