Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects

Regeneron Pharmaceuticals0 sites24 target enrollmentAugust 2013

ConditionsAllergy

InterventionsREGN1908-1909 placebo

DrugsREGN1908-1909

Overview

Phase: Phase 1
Intervention: REGN1908-1909
Conditions: Allergy
Sponsor: Regeneron Pharmaceuticals
Enrollment: 24
Primary Endpoint: Safety
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy men and women between the ages of 18 and 55
•Positive allergen skin prick test
•Willing and able to comply with clinic visits and study-related procedures
•Provide signed informed consent

Exclusion Criteria

•Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
•Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
•Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
•Hospitalization for any reason within 60 days prior to the screening visit
•Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
•Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results
•The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.