Clinical Trials/NCT03115996

NCT03115996

Completed

Phase 1

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.

Regeneron Pharmaceuticals1 site in 1 country56 target enrollmentMay 10, 2017

ConditionsHealthy Volunteers

InterventionsREGN3918 Placebo

DrugsREGN3918 Placebo

Overview

Phase: Phase 1
Intervention: REGN3918
Conditions: Healthy Volunteers
Sponsor: Regeneron Pharmaceuticals
Enrollment: 56
Locations: 1
Primary Endpoint: Incidence of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.

Detailed Description

Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.

Registry

clinicaltrials.gov

Start Date

May 10, 2017

End Date

August 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject must meet the follow criteria to be eligible for inclusion in the study:
•Males and females from 18 to 50 years of age.
•Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
•The subject has a body mass index less than 30 kg/m2
•Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.

Exclusion Criteria

•A subject who meets any of the following criteria will be excluded from the study:
•Any clinically significant physical examination abnormalities observed during the screening visit.
•Hospitalization for any reason within 30 days of the screening visit
•Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
•Subject has a history of meningococcal infection.
•Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
•Subject has had a splenectomy.
•Known allergy to penicillin class antibiotics
•Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening.
•Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment.

Arms & Interventions

REGN3918 (Cohorts 1-4 & 6a)

Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918

Intervention: REGN3918

Placebo (Cohorts 1-4 & 6a)

Cohorts 1-4 and 6a will receive placebo

Intervention: Placebo

REGN3918 (Cohort 5 & 6b)

Cohort 5 and 6b will receive multiple doses of REGN3918

Intervention: REGN3918

Placebo (Cohort 5 & 6b)

Cohort 5 and 6b will receive placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events (TEAEs)

Time Frame: Up to 20 weeks

Severity of TEAEs

Time Frame: Up to 20 weeks

Secondary Outcomes

Pharmacodynamics profile of REGN3918(Up to 20 weeks)
Pharmacokinetic profile of REGN3918; single dose IV and SC(Up to 20 weeks)
Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses(Up to 20 weeks)
Pharmacokinetic exploratory analysis(Up to 20 weeks)
Immunogenicity of REGN3918(Up to 20 weeks)