A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults
- Registration Number
- NCT05923424
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Expansion Cohort 3 REGN17092 Randomized 3:1 for single ascending dose Cohort 1 Mid IV Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 1 Mid IV Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 3 High IV Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 3 High IV Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 5 Higher IV Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 6 Low IV Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 2 Mid SC Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 4 High SC Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 4 High SC Dose Matching Placebo Randomized 6:2 for single ascending dose Cohort 7 Low SC Dose Matching Placebo Randomized 6:2 for single ascending dose Expansion Cohort 1 Matching Placebo Randomized 3:1 for single ascending dose Expansion Cohort 2 REGN17092 Randomized 3:1 for single ascending dose Expansion Cohort 2 Matching Placebo Randomized 3:1 for single ascending dose Expansion Cohort 3 Matching Placebo Randomized 3:1 for single ascending dose Cohort 5 Higher IV Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 6 Low IV Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 2 Mid SC Dose REGN17092 Randomized 6:2 for single ascending dose Cohort 7 Low SC Dose REGN17092 Randomized 6:2 for single ascending dose Expansion Cohort 1 REGN17092 Randomized 3:1 for single ascending dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Concentrations of REGN17092 in serum over time Through approximately day 365 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
Trial Locations
- Locations (1)
UZ Leuven Gasthuisberg Campus
🇧🇪Leuven, Belgium