Healthy Volunteers
Conditions
Keywords
Severe acute respiratory syndrome coronavirus (SARS-CoV-19), Coronavirus disease 2019 (COVID-19) vaccinated, Omicron variant
Brief 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)
Interventions
DRUGREGN17092
Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
DRUGMatching Placebo
Single ascending IV or SC administration per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of all treatment emergent adverse events (TEAEs) | Through approximately day 365 |
| Severity of all TEAEs | Through approximately day 365 |
| Occurrence of all treatment emergent serious adverse events (TE-SAEs) | Through approximately day 365 |
| Severity of all TE-SAEs | Through approximately day 365 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time | Through approximately day 365 |
| Titer of ADAs to REGN17092 over time | Through approximately day 365 |
| Concentrations of REGN17092 in serum over time | Through approximately day 365 |
Countries
Belgium
Outcome results
None listed