Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral TYK2 Inhibitor D-2570 in Healthy Subjects: A First-in-Human Phase I Study.

ABSTRACT: D-2570 selectively binds to the pseudokinase domain of tyrosine kinase 2, which mediates the downstream cytokine signaling pathways involved in immune regulation. The safety, tolerability, pharmacokinetics, and pharmacodynamics of D-2570 were evaluated in a randomized, double-blind, placebo-controlled phase I study conducted in healthy Chinese subjects. The study consisted of three parts: single ascending dose (D-2570: 3-48 mg once daily) study, multiple ascending dose (D-2570: 6-36 mg once daily for 10 days) study, and food effect (D-2570: 9 mg) study. D-2570 was rapidly absorbed, with peak plasma concentration at around 4 h and exposure increased sub-proportional across the dose groups. Following multiple dosing, mean terminal elimination half-lives at steady state ranged from 22.22 to 3

SUBMITTER: Wang M 

PROVIDER: S-EPMC12802081 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature