The randomized, single- and multiple- ascending dose studies of the safety, tolerability, pharmacokinetics of CSPCHA115 in healthy Chinese subjects.

ABSTRACT: CSPCHA115 is a highly selective and potent antagonist of chemoattractant receptor-homologous molecule expressed on TH2 cells (CRTH2). This study aimed to evaluate the pharmacokinetics (PKs), safety, and tolerability of single and multiple ascending doses of CSPCHA115 in Chinese healthy subjects. Two phase I studies both adopted a randomized, double-blind, placebo-controlled, single-center, and ascending-dose design. In the single ascending dose (SAD) study, subjects were randomly allocated to receive a single dose of CSPCHA115 (25-1000 mg) or a placebo. In the multiple ascending dose (MAD) study, 100, 200, 400, or 600 mg of CSPCHA115 or placebo were given to subjects once daily for 7 days. PK parameters were estimated by noncompartmental analysis. Safety was assessed by monitoring treatmen

SUBMITTER: Jing S 

PROVIDER: S-EPMC10014699 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature