A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers

Regeneron Pharmaceuticals1 site in 1 country57 target enrollmentNovember 19, 2020

ConditionsHealthy Volunteer

InterventionsPlacebo REGN6490

DrugsREGN6490 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteer
Sponsor: Regeneron Pharmaceuticals
Enrollment: 57
Locations: 1
Primary Endpoint: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants

The secondary objectives of the study are to:

Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490

Registry

clinicaltrials.gov

Start Date

November 19, 2020

End Date

June 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
•Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
•Is in good health based on laboratory safety testing obtained at the screening visit
•Willing and able to comply with clinic visits and study-related procedures
•Provide informed consent signed by study participant

Exclusion Criteria

•History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
•Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
•Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
•Hospitalization (\>24 hours) for any reason within 30 days of the screening visit
•Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit
•Note: Other protocol defined Inclusion/Exclusion criteria apply