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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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1Y 4G2 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Allergic Rhinitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01723254
Pfizer
Completed
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis

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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
A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-ige Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
  • Biological: IGE-1
    Intramuscular, multiple dose
  • Biological: IGE-2
    Intramuscular, multiple dose
  • Biological: Saline
    Saline (0.9% sodium chloride)
  • Experimental: PF-06444753
    Intervention: Biological: IGE-1
  • Experimental: PF-06444752
    Intervention: Biological: IGE-2
  • Placebo Comparator: Placebo
    Intramuscular
    Intervention: Biological: Saline
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
June 2015
June 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01723254
B4901001
ANTI- IGE VACCINE ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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