A Phase I Study to Evaluate the Pharmacokinetics and Safety of Nolasiban in Healthy Volunteers

The primary objective of this study is to evaluate the pharmacokinetics and safety of nolasiban. Assessment of these parameters is essential for characterizing the absorption, distribution, metabolism, and excretion of the compound in healthy subjects.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including females, within the specified age range. This is a pharmacokinetic study.

This Phase 3 clinical trial is designed to evaluate the pharmacokinetics and safety of nolasiban in healthy subjects. The study follows a structured protocol involving a screening visit to determine eligibility, followed by specific study visits to monitor the administration and physiological response to the investigational product. The total duration of the study period is estimated to occur between February 2026 and July 2026. Participants will undergo scheduled follow-up visits and an end-of-study visit to ensure comprehensive data collection. Individual involvement may be subject to early termination if predefined clinical criteria or safety protocols are met.

This study is a pharmacokinetic study conducted in healthy subjects. No efficacy parameters or endpoints are evaluated.