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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: REGN14284; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • Universitair Ziekenhuis Leuven Gasthuisberg Campus

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

1. Has 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/m2 (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, laboratory safety testing and ECGs performed at screening and/or prior to administration 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 a history of alcohol or drug abuse as determined by the investigator
5. 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
6. 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
7. 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 Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Mid IV Dose; Randomized 3:1 for single ascending dose	Drug: REGN14284; 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 3:1 for single ascending dose	Drug: REGN14284; 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 3:1 for single ascending dose	Drug: REGN14284; 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 3:1 for single ascending dose	Drug: REGN14284; 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 3:1 for single ascending dose	Drug: REGN14284; 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 Highest IV Dose; Randomized 3:1 for single ascending dose	Drug: REGN14284; 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 IV Dose; Randomized 3:1 for single ascending dose	Drug: REGN14284; 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 8 Low SC Dose; Randomized 3:1 for single ascending dose	Drug: REGN14284; Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol; Drug: Matching Placebo; Single ascending IV or SC administration per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Concentrations of REGN14284 in serum over time	Through approximately day 169
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time	Through approximately day 90
Titer of ADAs to REGN14284 over time	Through approximately day 90

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Coronavirus disease 2019 (COVID-19) vaccinated; Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: R14284-HV-2253; 2022-002181-33 (EudraCT 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: No
• Studies a U.S. FDA-regulated device product: No