Kangpu Biopharmaceuticals doses first humans with KPG-818 for treating SLE and hematological malignancies
October 11, 2019Kangpu Biopharmaceuticals has completed a first-in-human phase I single ascending dose (SAD) clinical study in the United States, testing KPG-818 for the treatment of SLE and hematological malignancies.
The study was conducted with 40 healthy male and female participants following oral administrationwho were randomized to receive active drug or placebo in a double-blind fashion.
In the completed phase I study, there were no safety or tolerability concerns, the company said in the press release on Friday. It also said that no serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met, and that KPG-818 was well tolerated at all tested dose levels.
Furthermore, KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.
Kangpu Biopharmaceuticals said they will use the study results in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.