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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Allergic Rhinitis

Treatments

Biological: IGE-1
Biological: IGE-2
Biological: Saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT01723254
B4901001
ANTI- IGE VACCINE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

190 participants in 3 patient groups, including a placebo group

PF-06444753
Experimental group
Treatment:
Biological: IGE-1
PF-06444752
Experimental group
Treatment:
Biological: IGE-2
Placebo
Placebo Comparator group
Description:
Intramuscular
Treatment:
Biological: Saline

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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