Kangpu Biopharmaceuticals, a clinical-stage company based in Hefei, China, announced today that the Company has successfully completed a bridging clinical study of KPG-818 in healthy subjects in China.
The randomized, double-blind, placebo-controlled, and food effects (FE) study aimed to assess the safety and tolerability of multiple oral doses of KPG-818 in male and female healthy participants over a treatment period of 14 days and a follow-up period of 4 weeks, to characterize the single and multiple oral dose pharmacokinetics (PK) of KPG-818, and to select dosing regimens of KPG-818 for future clinical trials. A total of 30 participants were randomized to three escalating cohorts (n=10 each; 8 KPG-818, 2 placebo) receiving 0.15 mg, 0.6 mg, 2 mg or placebo once daily. In the FE cohort, 12 participants received single dose of 0.6 mg KPG-818 with and without food.
KPG-818 is well tolerated in healthy subjects. No serious adverse events (SAEs) were reported. The most common AEs were grades 1-2 of pruritus or rash.
Close to linear PK of KPG-818 was observed in the dosing range of 0.15 mg-2 mg. Similar exposure was observed for KPG-818 under fed/fasted conditions.
