A Phase I Dose-Escalation Study to Evaluate the Safety and Tolerability of BI 3814916 in Healthy Volunteers

The primary objective is to evaluate the tolerability of varying doses of BI 3814916 in healthy volunteers. This assessment is clinically relevant for establishing the safety profile and determining acceptable dosage ranges in a non-diseased population. Trial scope: 4.

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 age ranges of 3 to 5 years and 6 to 11 years.

This Phase 1 clinical trial is designed to evaluate the tolerability of various doses of BI 3814916 in healthy volunteers. The research methodology involves a controlled study design to determine the safety profile of the investigated substance. The sequence of study procedures begins with a screening visit to assess eligibility. Following screening, participants undergo subsequent study visits to monitor physiological responses to the administered doses. The protocol concludes with an end-of-study visit to perform final evaluations. The overall duration of the trial is estimated to conclude by February 15, 2027. Specific conditions leading to early termination from the study are governed by established safety protocols.

The assessment of efficacy within this Phase 1 clinical trial involving healthy volunteers is not specified.