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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo injection SC/IV | Placebo Comparator | Placebo for injection SC/IV |
|
| PF-06823859 | Active Comparator | Study Drug being used in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06823859 | Biological | Comparison of different dosages of PF-06823859 to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs | Safety | Dosing through approximately Day 189 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Clearance (CL) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859 | Pharmacokinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41874840 | Derived | 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. | |
| 33352008 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Placebo injection SC/IV | Drug | Comparison of Placebo to different doses of PF-06823859 |
|
|
| Pre dose to approximately Day 189 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859 | Immunogenicity | Pre dose to approximately Day 189 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Maximum Observed Plasma Concentration (Cmax) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Plasma Decay Half-Life (t1/2) | Pharmacokinetics | Pre dose to approximately Day 189 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously | Pharmacokinetics | Pre dose to approximately Day 189 |
| Volume of Distribution at Steady State (Vss) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| AUCtau (dose normalized) | Pharmacokinetics | Pre dose to approximately Day 189 |
| C av of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Mean residence of time for PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 |
| To obtain contact information for a study center near you, click here. | View source |