A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
- Registration Number
- NCT05505448
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of REGN14284 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
The secondary objectives of the study are:
* To assess the concentration-time profile of REGN14284 in serum
* To assess the immunogenicity of REGN14284
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Has 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/m2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration 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 a history of alcohol or drug abuse as determined by the investigator
- Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol
- Use of any medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed as described in the protocol
- Participated in any clinical research study evaluating another investigational drug including biologics or specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit
NOTE: Other protocol defined inclusion / exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 6 Highest IV Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 4 High SC Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 1 Mid IV Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 7 Low IV Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 7 Low IV Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 8 Low SC Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 1 Mid IV Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 2 Mid SC Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 4 High SC Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 2 Mid SC Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 3 High IV Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 5 Higher IV Dose Matching Placebo Randomized 3:1 for single ascending dose Cohort 3 High IV Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 8 Low SC Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 5 Higher IV Dose REGN14284 Randomized 3:1 for single ascending dose Cohort 6 Highest IV Dose REGN14284 Randomized 3:1 for single ascending dose
- Primary Outcome Measures
Name Time Method Occurrence and severity of all treatment emergent adverse events (TEAEs) Through approximately day 169 Occurrence and severity of all severe adverse events (SAEs) Through approximately day 169
- Secondary Outcome Measures
Name Time Method Concentrations of REGN14284 in serum over time Through approximately day 169 Titer of ADAs to REGN14284 over time Through approximately day 90 Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time Through approximately day 90
Trial Locations
- Locations (1)
Universitair Ziekenhuis Leuven Gasthuisberg Campus
🇧🇪Leuven, Belgium