NCT05923424

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2023

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

June 20, 2023

Last Update Submit

March 26, 2025

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (10)

Cohort 1 Mid IV Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 3 High IV Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 5 Higher IV Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 6 Low IV Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 2 Mid SC Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 4 High SC Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Cohort 7 Low SC Dose

EXPERIMENTAL

Randomized 6:2 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Expansion Cohort 1

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Expansion Cohort 2

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Expansion Cohort 3

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN17092Drug: Matching Placebo

Interventions

REGN17092DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Cohort 1 Mid IV DoseCohort 2 Mid SC DoseCohort 3 High IV DoseCohort 4 High SC DoseCohort 5 Higher IV DoseCohort 6 Low IV DoseCohort 7 Low SC DoseExpansion Cohort 1Expansion Cohort 2Expansion Cohort 3
Matching PlaceboDRUG

Single ascending IV or SC administration per the protocol

Cohort 1 Mid IV DoseCohort 2 Mid SC DoseCohort 3 High IV DoseCohort 4 High SC DoseCohort 5 Higher IV DoseCohort 6 Low IV DoseCohort 7 Low SC DoseExpansion Cohort 1Expansion Cohort 2Expansion Cohort 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Has a 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/m\^2 (inclusive) at the screening visit
  • 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

You may not qualify if:

  • 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 history of alcohol or drug abuse as determined by the investigator
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven Gasthuisberg Campus

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

November 28, 2023

Primary Completion

March 4, 2025

Study Completion

March 4, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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
More information

Locations

BE(1)