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

• ClinicalTrials.gov Identifier: NCT05923424
• Recruitment Status: Active, not recruiting
• First Posted: June 28, 2023
• Last Update Posted: April 2, 2024
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: REGN17092; Drug: Matching Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 28, 2023
• Estimated Primary Completion Date: April 30, 2025
• Estimated Study Completion Date: April 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Occurrence of all treatment emergent adverse events (TEAEs) [ Time Frame: Through approximately day 365 ]
2. Severity of all TEAEs [ Time Frame: Through approximately day 365 ]
3. Occurrence of all treatment emergent serious adverse events (TE-SAEs) [ Time Frame: Through approximately day 365 ]
4. Severity of all TE-SAEs [ Time Frame: Through approximately day 365 ]

Secondary Outcome Measures :

1. Concentrations of REGN17092 in serum over time [ Time Frame: Through approximately day 365 ]
2. Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time [ Time Frame: Through approximately day 365 ]
3. Titer of ADAs to REGN17092 over time [ Time Frame: Through approximately day 365 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Belgium

UZ Leuven Gasthuisberg Campus

Leuven, Belgium, 3000

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:

Informed Consent Form  [PDF] August 1, 2023

More Information

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05923424
• Other Study ID Numbers: R17092-HV-2312; 2023- 505041-52-00 ( Registry Identifier: EU CT Number )
• First Posted: June 28, 2023
• Last Update Posted: April 2, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• 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.
• 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
• URL: https://vivli.org/

• 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

Keywords provided by Regeneron Pharmaceuticals:

Severe acute respiratory syndrome coronavirus (SARS-CoV-19); Coronavirus disease 2019 (COVID-19) vaccinated; Omicron variant