Pharmacokinetics, Immunogenicity, and Safety Comparison of PB016 and US-Licensed Vedolizumab in Healthy Volunteers After Subcutaneous Administration

The primary objective of this study is to compare the pharmacokinetics, immunogenicity, and safety of a single subcutaneous dose of PB016 relative to the US-licensed Entyvio in healthy participants. Evaluating these parameters is essential to establish the comparative profile of the investigational product against an existing standard of care. The secondary evaluation involves the assessment of safety and pharmacokinetics following 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 belong to an age group categorized by code 3. This study population includes vulnerable populations.

This Phase 3, randomized, double-blind, 2-arm parallel-group study is designed to compare the pharmacokinetics, immunogenicity, and safety of a single subcutaneous dose of PB016 against the US-licensed Entyvio in healthy volunteers. The research methodology involves the administration of either the investigational product or the comparator drug to evaluate the pharmacological and immunological responses. The study sequence commences with a screening visit to assess eligibility, followed by the administration phase and subsequent follow-up visits to monitor physiological parameters. The protocol concludes with an end-of-study visit to complete the safety assessment. The total duration of participant involvement is determined by the established follow-up schedule, and the study may be subject to early termination based on predefined safety criteria or protocol deviations.

The provided documentation does not contain information regarding efficacy assessment parameters, measurement methods, or clinical instruments.