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

June 9, 2014 updated by: Regeneron Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
  2. Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
  3. 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
  4. Hospitalization for any reason within 60 days prior to the screening visit
  5. 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
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dose 1 of REGN1908-1909 or placebo
Other: placebo
Drug: REGN1908-1909
Experimental: Cohort 2
Dose 2 of REGN1908-1909 or placebo
Other: placebo
Drug: REGN1908-1909
Experimental: Cohort 3
Dose 3 of REGN1908-1909 or placebo
Other: placebo
Drug: REGN1908-1909

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: day 1 to day 113
The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).
day 1 to day 113

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentration
Time Frame: day 1 to day 113
The secondary endpoint is serum concentrations of REGN1908-1909 over time.
day 1 to day 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • R1908-HV-1240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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