Trials / Completed
CompletedNCT02743871
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
Detailed description
The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024 in healthy subjects. The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps. The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-06817024 | Subjects will be given one dose of PF-06817024 intravenously |
| OTHER | Placebo for PF-06817024 | Subjects will be given one dose of placebo for PF-06817024 intravenously |
| BIOLOGICAL | PF-06817024 | Subjects will be given one dose of PF-06817024 subcutaneously |
| OTHER | Placebo for PF-06817024 | Subjects will be given one dose of placebo for PF-06817024 subcutaneously |
| BIOLOGICAL | PF-06817024 | Subjects will be given two doses of PF-06817024 intravenously |
| OTHER | Placebo for PF-06817024 | Subjects will be given two doses of PF-06817024 intravenously |
| BIOLOGICAL | PF-06817024 | Subjects will be given 2 doses intravenously |
| OTHER | Placebo for PF-06817024 | Subjects will be given 2 doses intravenously |
| BIOLOGICAL | PF-06817024 | Subjects will be given doses of PF-06817024 intravenously |
| OTHER | Placebo for PF-06817024 | Subjects will be given doses of Placebo intravenously |
Timeline
- Start date
- 2016-04-27
- Primary completion
- 2021-03-09
- Completion
- 2021-03-09
- First posted
- 2016-04-19
- Last updated
- 2022-05-19
- Results posted
- 2022-05-19
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02743871. Inclusion in this directory is not an endorsement.