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

NCT05505448 | Completed Phase 1

• 2 other identifiers: R14284-HV-22532022-002181-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Coronavirus disease 2019 (COVID-19) vaccinated; Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (8)

Cohort 1 Mid IV Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 2 Mid SC Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 3 High IV Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 4 High SC Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 5 Higher IV Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 6 Highest IV Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 7 Low IV Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Cohort 8 Low SC Dose

EXPERIMENTAL

Randomized 3:1 for single ascending dose

Drug: REGN14284; Drug: Matching Placebo

Interventions

REGN14284 DRUG

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

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

Matching Placebo DRUG

Single ascending IV or SC administration per the protocol

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, B-3000, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract 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: August 15, 2022
• First Posted: August 17, 2022
• Study Start: September 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• 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

Locations

BE (1)