Lumosa Announces the Completion of the Phase 1 Clinical Trial on the Pharmacokinetics of Multiple Doses and the Drug-Drug Interaction for LT3001. Planned development stages:Phase 2, Phase 3, NDA. Current development stage:Phase 2. The completion of the study report for the Phase 1 trial on the pharmacokinetics of multiple dose regimen and drug-drug interaction of LT3001.

Study title: A Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult. To determine the safety, tolerability, and PK of a 3-day thrice daily use of LT3001 drug product, when administered as an IV infusion q3h between each dose within one day in healthy subjects. To determine the safety and PK of LT3001 when co-administered with aspirin,clopidogrel, apixaban or dabigatran.

Statistical results of primary and secondary endpoints (including but not limited to p value) and statistical significance (including but not limited to whether or not statistical significance was reached). Provide explanation if the company cannot disclose statistical data due to other important reasons. The 3-day thrice daily multiple dose regimen of LT3001 was found to be safe and well tolerated.

The adverse events of the three subjects were mild and not related to the study drug. No clinical meaningful changes were found in the physical examination, ECG assessment, hematology and biochemistry tests, platelet functions and coagulation functions after multiple doses of LT3001 were administered to the subjects. No significant changes in terms of the pharmacokinetics parameters for the three-day regimen when compared to that with the single dose administration.

The possibility of drug accumulation in multiple dosing may be extremely low. The study also simultaneously assesses the difference of LT3001 between Chinese and non-Asian Americans and the results showed that the pharmacokinetics between the two groups were similar.