drugset / Trial / NCT02743871
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
RandomizedSequentialQuadruple-blindTreatment
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
Timeline
- Start
- 2016-04-27
- Primary completion
- 2021-03-09
- Completion
- 2021-03-09
Publications
- Danto SI, Tsamandouras N, Reddy P, Gilbert SA, Mancuso JY, Page K, Beebe JS, Peeva E, Vincent MS. Exploratory pharmacodynamics and efficacy of PF-06817024 in a Phase 1 study of patients with chronic rhinosinusitis and atopic dermatitis. Allergy Asthma Clin Immunol. 2024 Aug 30;20(1):46. doi: 10.1186/s13223-024-00894-8.
- Danto SI, Tsamandouras N, Reddy P, Gilbert S, Mancuso J, Page K, Peeva E, Vincent MS, Beebe JS. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-06817024 in Healthy Participants, Participants with Chronic Rhinosinusitis with Nasal Polyps, and Participants with Atopic Dermatitis: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Pharmacol. 2024 May;64(5):529-543. doi: 10.1002/jcph.2360. Epub 2023 Oct 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PF-06817024 | Monoclonal antibody | 10 mg | Intravenous |
| Subject | PF-06817024 | Monoclonal antibody | 30 mg | Intravenous |
| Subject | PF-06817024 | Monoclonal antibody | 100 mg | Intravenous |
| Subject | PF-06817024 | Monoclonal antibody | 300 mg | Intravenous |
| Subject | PF-06817024 | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | PF-06817024 | Monoclonal antibody | 2000 mg | Intravenous |