A Comparative Study of Prefilled Syringe and Autoinjector Delivery Formulations of FYB202 in Patients with Chronic Inflammatory Diseases

The primary objective of this study is to compare the prefilled syringe and autoinjector presentations of FYB202 in patients with chronic inflammatory diseases. This evaluation is intended to assess the performance and usability of different delivery formats for this therapeutic agent. There are no secondary objectives reported.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female individuals. The subjects belong to an age group categorized by code 3, and the cohort includes vulnerable populations. Participants are characterized by the absence of chronic inflammatory diseases.

This Phase 2 clinical trial is designed as a comparative study to evaluate different delivery presentations of FYB202 in patients with chronic inflammatory diseases. The research methodology involves a comparison between a prefilled syringe and an autoinjector. The study sequence begins with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor clinical progress and safety. The protocol concludes with an end-of-study visit. The estimated duration for recruitment and study activities spans from September 2025 to May 2026. Participation may be subject to early termination based on predefined clinical conditions.

The assessment of efficacy in this Phase 2 clinical trial involves the evaluation of therapeutic response in subjects with chronic inflammatory diseases.