NCT05845645

A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharmacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B

A 2-Part Study to Evaluate the Relative Bioavailability of 2 New Formulations of UCB0599 and the Effect of Esomeprazole on the PK of UCB0599 in Healthy Participants (Part A, Open-Label) and to Assess the Safety/Tolerability and PK of UCB0599 in Healthy Participants of Japanese and Chinese Origins (Part B, Double-Blind)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	UCB0599	Study participants will receive pre-specified doses of UCB0599 in 3 different formulations administered orally in a pre-specified sequence during the Treatment Periods of Part A and B
OTHER	Esomeprazole	Study participants will receive fixed dose of esomeprazole administered orally in a pre-specified sequence during the Treatment Period of Part A. This is a non-investigational medicinal product (NIMP) in this study.
OTHER	Placebo	Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B.

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-04-13
• Completion: 2024-04-13
• First posted: 2023-05-06
• Last updated: 2025-12-22
• Results posted: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study