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

Sponsoren

Hauptsponsor: Pfizer

Quelle Pfizer
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum December 2012
Fertigstellungstermin June 2015
Primäres Abschlussdatum June 2015
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination Within 14 days
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination Within 14 days
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs Baseline up to 336 days post study administration or at Early Termination
Number of Participants With Laboratory Test Abnormalities Baseline up to 336 days post last study drug administration or Early Termination
Sekundäres Ergebnis
Messen Zeitfenster
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)
Einschreibung 190
Bedingung
Intervention

Interventionsart: Biological

Interventionsname: IGE-1

Beschreibung: Intramuscular, multiple dose

Armgruppenetikett: PF-06444753

Interventionsart: Biological

Interventionsname: IGE-2

Beschreibung: Intramuscular, multiple dose

Armgruppenetikett: PF-06444752

Interventionsart: Biological

Interventionsname: Saline

Beschreibung: Saline (0.9% sodium chloride)

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

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).

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 55 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Pfizer CT.gov Call Center Study Director Pfizer
Ort
Einrichtung:
Ottawa Allergy Research Corporation | Ottawa, Ontario, K1Y 4G2, Canada
Diex Research Montreal Inc. | Montreal, Quebec, H4N 3C5, Canada
Diex Research Sherbrooke Inc. | Sherbrooke, Quebec, J1H 1Z1, Canada
Centre de Recherche Appliquee en Allergie de Quebec | Quebec, G1V 4M6, Canada
Standort Länder

Canada

Überprüfungsdatum

May 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: PF-06444753

Art: Experimental

Etikette: PF-06444752

Art: Experimental

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: Intramuscular

Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov