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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

NCT05845645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-12-22

Study results available
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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

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.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-04-13
Completion
2024-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845645 on ClinicalTrials.gov