A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

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

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)

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Matching Placebo; Drug: REGN17092

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Mid IV Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 3 High IV Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 5 Higher IV Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 6 Low IV Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 2 Mid SC Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 4 High SC Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Cohort 7 Low SC Dose; Randomized 6:2 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Expansion Cohort 1; Randomized 3:1 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Expansion Cohort 2; Randomized 3:1 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Experimental: Expansion Cohort 3; Randomized 3:1 for single ascending dose	Drug: Matching Placebo; Single ascending IV or SC administration per the protocol; Drug: REGN17092; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): March 4, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Coronavirus disease 2019 (COVID-19) vaccinated; Severe acute respiratory syndrome coronavirus (SARS-CoV-19); Omicron variant
• Other Study ID Numbers: R17092-HV-2312; 2023- 505041-52-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes