search
Back to results

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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
REGN14284
Matching Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Coronavirus disease 2019 (COVID-19) vaccinated, Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Leuven Gasthuisberg Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 Mid IV Dose

Cohort 2 Mid SC Dose

Cohort 3 High IV Dose

Cohort 4 High SC Dose

Cohort 5 Higher IV Dose

Cohort 6 Highest IV Dose

Cohort 7 Low IV Dose

Cohort 8 Low SC Dose

Arm Description

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Randomized 3:1 for single ascending dose

Outcomes

Primary Outcome Measures

Occurrence and severity of all treatment emergent adverse events (TEAEs)
Occurrence and severity of all severe adverse events (SAEs)

Secondary Outcome Measures

Concentrations of REGN14284 in serum over time
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Titer of ADAs to REGN14284 over time

Full Information

First Posted
August 15, 2022
Last Updated
July 25, 2023
Sponsor
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05505448
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Coronavirus disease 2019 (COVID-19) vaccinated, Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Mid IV Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 2 Mid SC Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 3 High IV Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 4 High SC Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 5 Higher IV Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 6 Highest IV Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 7 Low IV Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Arm Title
Cohort 8 Low SC Dose
Arm Type
Experimental
Arm Description
Randomized 3:1 for single ascending dose
Intervention Type
Drug
Intervention Name(s)
REGN14284
Intervention Description
Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Single ascending IV or SC administration per the protocol
Primary Outcome Measure Information:
Title
Occurrence and severity of all treatment emergent adverse events (TEAEs)
Time Frame
Through approximately day 169
Title
Occurrence and severity of all severe adverse events (SAEs)
Time Frame
Through approximately day 169
Secondary Outcome Measure Information:
Title
Concentrations of REGN14284 in serum over time
Time Frame
Through approximately day 169
Title
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Time Frame
Through approximately day 90
Title
Titer of ADAs to REGN14284 over time
Time Frame
Through approximately day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit 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: 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 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 Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit Has a history of alcohol or drug abuse as determined by the investigator 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Leuven Gasthuisberg Campus
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/

Learn more about this trial

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

We'll reach out to this number within 24 hrs