NCT02127801CompletedPhase 1
A Single Dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic Rhinitis Subjects Challenged Intranasally With Allergen Extract
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 74
- Primary Endpoint
- Change in allergic symptom scale score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A
Experimental
Participants in group A will receive REGN1908-1909
Intervention: REGN1908-1909 (Drug)
Group B
Experimental
Participants in group B will receive placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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
- 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)(day 1 to day 85)
- Incidence rate of treatment-emergent adverse events (TEAEs) through day 85 in participants treated with REGN1908-1909 or placebo(day 1 to day 85)
Investigators
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