Clinical trial NCT05923424: A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Severe acute respiratory syndrome coronavirus (SARS-CoV-19)
Coronavirus disease 2019 (COVID-19) vaccinated
Omicron variant
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)


Eligibility 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 / exclusion criteria apply

Primary outcomes:
measure: Occurrence of all treatment emergent adverse events (TEAEs)
timeFrame: Through approximately day 365
measure: Severity of all TEAEs
timeFrame: Through approximately day 365
measure: Occurrence of all treatment emergent serious adverse events (TE-SAEs)
timeFrame: Through approximately day 365
measure: Severity of all TE-SAEs
timeFrame: Through approximately day 365
Secondary outcomes:
measure: Concentrations of REGN17092 in serum over time
timeFrame: Through approximately day 365
measure: Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time
timeFrame: Through approximately day 365
measure: Titer of ADAs to REGN17092 over time
timeFrame: Through approximately day 365
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg Campus
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: