drugset / Trial / NCT02766621
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
RandomizedParallel-groupDouble-blindBasic science
Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
Timeline
- Start
- 2016-05-27
- Primary completion
- 2017-08-30
- Completion
- 2017-09-26
Publications
- Prybylski JP, Zhu J', Banfield C, Mukherjee A, Purohit V. Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis. J Pharmacokinet Pharmacodyn. 2026 Mar 24;53(3):17. doi: 10.1007/s10928-026-10022-1.
- Neelakantan S, Oemar B, Johnson K, Rath N, Salganik M, Berman G, Pelletier K, Cox L, Page K, Messing D, Tarabar S. Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon beta Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study. Clin Pharmacol Drug Dev. 2021 Mar;10(3):307-316. doi: 10.1002/cpdd.887. Epub 2020 Dec 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | dazukibart | Monoclonal antibody | 30 mg | Intravenous |
| Comparator | dazukibart | Monoclonal antibody | 100 mg | Intravenous |
| Comparator | dazukibart | Monoclonal antibody | 300 mg | Intravenous |
| Comparator | dazukibart | Monoclonal antibody | 600 mg | Intravenous |
| Comparator | dazukibart | Monoclonal antibody | 900 mg | Intravenous |
| Comparator | dazukibart | Monoclonal antibody | 2000 mg | Intravenous |
Indications
No indication recorded.