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

July 25, 2023 updated by: Regeneron Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence and severity of all treatment emergent adverse events (TEAEs)
Time Frame: Through approximately day 169
Through approximately day 169
Occurrence and severity of all severe adverse events (SAEs)
Time Frame: Through approximately day 169
Through approximately day 169

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Concentrations of REGN14284 in serum over time
Time Frame: Through approximately day 169
Through approximately day 169
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Time Frame: Through approximately day 90
Through approximately day 90
Titer of ADAs to REGN14284 over time
Time Frame: Through approximately day 90
Through approximately day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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