Skip to main content
OpenTrials
Completed

NCT Number: NCT05505448

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, B-3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN14284

Drug

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

Matching Placebo

Drug

Single ascending IV or SC administration per the protocol

Primary outcomes

  1. Occurrence and severity of all treatment emergent adverse events (TEAEs)

    Time frame: Through approximately day 169

  2. Occurrence and severity of all severe adverse events (SAEs)

    Time frame: Through approximately day 169

Secondary outcomes

  1. Concentrations of REGN14284 in serum over time

    Time frame: Through approximately day 169

  2. Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time

    Time frame: Through approximately day 90

  3. Titer of ADAs to REGN14284 over time

    Time frame: Through approximately day 90

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.