CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 97 enrolled
Drug / intervention
PF-06817024 +9 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Healthy subjects aged 18–55 years (Part 1)
  • ✓Subjects with chronic rhinosinusitis with nasal polyps, aged 18–65 years, with ≥2 of: nasal congestion/obstruction, nasal discharge, face pain/pressure, or reduction/loss of smell (Part 2)
  • ✓Subjects with moderate-to-severe atopic dermatitis, aged 18–75 years, willing to avoid prolonged sun exposure and tanning devices (Part 3)
  • ✓Female subjects of non-childbearing potential or with documented bilateral tubal ligation/salpingectomy (Parts 1–2)
Key exclusion· 9
  • ✕Clinically significant cardiac, psychiatric, autoimmune, or renal disease
  • ✕Positive urine drug test
  • ✕Fever within 7 days of dosing
  • ✕Active infections within 28 days of dosing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02743871
NCT02743871Phase 1Completed
CompareCT.gov

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH MODERATE-SEVERE ATOPIC DERMATITIS

Pfizer·interventional·Posted Apr 19, 2016·Updated May 19, 2022

In Brief

A Phase 1 clinical trial evaluating PF-06817024 and Placebo for PF-06817024 for Healthy and 2 related conditions. Completed, enrolled 97 participants across 20 sites.

Detailed Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartApr 27, 2016
Primary CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.2 years ago

Interventions

PF-06817024biological

Subjects will be given one dose of PF-06817024 intravenously

Placebo for PF-06817024other

Subjects will be given one dose of placebo for PF-06817024 intravenously

PF-06817024biological

Subjects will be given one dose of PF-06817024 subcutaneously

Placebo for PF-06817024other

Subjects will be given one dose of placebo for PF-06817024 subcutaneously

PF-06817024biological

Subjects will be given two doses of PF-06817024 intravenously

Placebo for PF-06817024other

Subjects will be given two doses of PF-06817024 intravenously

PF-06817024biological

Subjects will be given 2 doses intravenously

Placebo for PF-06817024other

Subjects will be given 2 doses intravenously

PF-06817024biological

Subjects will be given doses of PF-06817024 intravenously

Placebo for PF-06817024other

Subjects will be given doses of Placebo intravenously