LP001(LintonPharm)

The objective of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of LP‐001 injection in healthy Chinese subjects. This was a single‐center, double‐blind, randomized, dose‐escalation study. Fifty‐six healthy adults were enrolled and randomly assigned to receive LP‐001 or matched placebo. A total of 156.0 drug related adverse events occurred during treatment in 38 subjects who received LP‐001 injection. The main events were grade 1 serum iron reduction and elevated triglycerides, which were considered related to the drug's erythropoietic effect and reversible. Pharmacokinetic exposure increased with dose (0.5–50 mcg·kg −1 ), but the increase in maximum plasma concentration (C max ) and area under the plasma concentration–time curve (AUC) was greater than the dose ratio (non‐linear). Pharmacodynamics showed dose‐dependent increases in hemoglobin (Hb), red blood cell count (RBC), hematocrit (HCT), and reticulocyte count (Rtc). The pharmacodynamic indicators in the 15 and 30 mcg·kg −1 multiple‐dose groups were significantly higher than those in the placebo group, and the increase in RBC count was more pronounced in the 30 mcg·kg −1 group. LP001, a long‐acting rhEPO, was safe and well‐tolerated at all doses in this Phase I study. These findings support its continued development as a treatment for myelodysplastic syndromes (MDS).