Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants

Phase 1 Completed 16 enrolled Telavant, Inc. Pfizer · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 1, randomized, double-blind, third-party open (ie, participant-blind, investigator-blind and sponsor-open), placebo-controlled, dose escalating clinical study to evaluate the safety, tolerability, immunogenicity, PK and PD of PF-06480605 in Japanese healthy adult participants.

Timeline

Start: 2020-02-19
Primary completion: 2020-11-11
Completion: 2020-11-11

Publications

Fukuhara K, Neelakantan S, Furihata K, Yuasa H, Shi N, Yamamoto Y, Hung KE. Japanese Phase 1 Study for Global Development of Anti-TL1A Antibody PF-06480605: A Randomized, Placebo-Controlled, Single-Ascending Dose Study. Clin Transl Sci. 2025 Mar;18(3):e70187. doi: 10.1111/cts.70187.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afimkibart	Monoclonal antibody	150 mg	Subcutaneous
Subject	Afimkibart	Monoclonal antibody	450 mg	Subcutaneous

Indications

No indication recorded.