Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants

Phase 1 Completed 13 enrolled Pfizer

RandomizedSequentialTriple-blindTreatment

Summary

Purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of PF-06823859 following a single intravenous dose of PF-06823859 300 and 900 mg in Japanese healthy adult participants.

Timeline

Start: 2021-09-28
Primary completion: 2022-03-27
Completion: 2022-03-27

Publications

Chen N, Sano Y, Wang X, Hu S, Tabira J, Luo X, Yoshimatsu H, Prybylski J, Chu M, Li H, Takazawa K. Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies. Clin Pharmacol Drug Dev. 2025 Aug;14(8):572-582. doi: 10.1002/cpdd.1522. Epub 2025 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dazukibart	Monoclonal antibody	300 mg	Intravenous
Subject	dazukibart	Monoclonal antibody	900 mg	Intravenous

Indications

No indication recorded.