A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to assess the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-06444753

Group Type EXPERIMENTAL

IGE-1

Intervention Type BIOLOGICAL

Intramuscular, multiple dose

PF-06444752

Group Type EXPERIMENTAL

IGE-2

Intervention Type BIOLOGICAL

Intramuscular, multiple dose

Placebo

Intramuscular

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type BIOLOGICAL

Saline (0.9% sodium chloride)

Interventions

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IGE-1

Intramuscular, multiple dose

Intervention Type BIOLOGICAL

IGE-2

Intramuscular, multiple dose

Intervention Type BIOLOGICAL

Saline

Saline (0.9% sodium chloride)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive,
* Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1 KU/L to at least one of the following common allergens: dust mite (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may compromise their ability to safely participate in the study.
* Evidence or history of clinically significant pulmonary disease (including allergic and non-allergic asthma, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary fibrosis, pulmonary hypertension, or others).
* Evidence or history of clinically significant autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, or others).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes