A Phase 1, Randomized, Crossover Study to Evaluate the Pharmacokinetics of Multiple Oral Dosing of CS014 Compared to Valproic Acid in Healthy Adults

The primary objective of this Phase 1 study is to evaluate the pharmacokinetics of multiple doses of CS014 compared to valproic acid through a 7-day repeat-dosing, crossover design in healthy adults. This assessment is clinically relevant for determining the absorption, distribution, metabolism, and excretion profiles of the investigational product during repeated administration.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants fall within the specified age range represented by codes 3 and 4. There is no reported data concerning lifestyle considerations or specific medical conditions for this cohort.

This Phase 1, open-label, randomized, 2-period, 2-sequence, crossover pharmacokinetic trial is designed to compare the effects of multiple oral doses of CS014 to valproic acid in healthy adults. The study utilizes a 7-days repeat-dosing regimen. The research methodology involves a structured sequence of study visits, beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor the physiological response to the administered substances, concluding with an end-of-study visit. The total duration of participant involvement is determined by the completion of the crossover periods. Early termination from the study may occur based on predefined clinical conditions or safety criteria.

The assessment of efficacy in this Phase 3 clinical trial focuses on the management of cardiopulmonary diseases characterized by thrombosis, remodelling of pulmonary vessels, and fibrosis.