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Completed

NCT Number: NCT02127801

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

The purposes of this study are to assess the efficacy, safety and tolerability of a single dose of REGN1908-1909 in allergic adult participants, to collect information about how much REGN1908-1909 is in blood over time and to collect information about how the body reacts to REGN1908-1909.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

REGN1908-1909

Drug

Placebo

Drug

Primary outcomes

  1. Change in allergic symptom scale score

    Time frame: At day 8

    The primary endpoint is the change in allergic symptom scale score at day 8

Secondary outcomes

  1. Incidence rate of treatment-emergent adverse events (TEAEs) through day 85 in participants treated with REGN1908-1909 or placebo

    Time frame: day 1 to day 85

  2. Pharmacokinetic (PK) parameters of REGN1908- REGN1909 administration (i.e. how much REGN1908-1909 is in blood over time and how the body reacts to REGN1908-1909)

    Time frame: day 1 to day 85

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Single Dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic Rhinitis Subjects Challenged Intranasally With Allergen Extract

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 1, 2014
Registry last updated
Dec 16, 2020

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.

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