A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharamacokinetic (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)

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).

Study Overview

• Status: Completed
• Conditions: Healthy Study Participants
• Intervention / Treatment: Drug: UCB0599; Other: Esomeprazole; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Up0073 10001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Part A only: all healthy study participants except for those participants who are eligible for Part B of the study
• For participants of Japanese origin (Part B): study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan). For participants of Chinese origin (Part B): study participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China).
• Body weight within 45 to 100 kg (female) and 50 to 100 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive at screening)
• Healthy male and female study participants

Exclusion Criteria:

• Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• Participant has a history or presence of/significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
• Participant has had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell carcinomas that have been resected, squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Participant has had breast cancer within the past 10 years
• Participant has a history of alcohol or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders
• Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
• Participant has a consumption of more than 600 mg of caffeine/day at screening and throughout the study
• Participant has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of study medication or is not willing to refrain from consuming these products for the duration of the study
• Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study
• Participant has participated in another study of a study medication (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an study medication (and/or an investigational device)
• Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing
• Positive hepatitis C antibody test (HCVAb) result at screening or within 3 months prior to starting study intervention
• Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study medication
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• For women of childbearing potential, study participant is pregnant, planning on becoming pregnant during the study, or is breastfeeding
• Participants who may have a history of confirmed gastric ulceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Study participants enrolled and randomized to this arm will receive a single dose of UCB0599 in 3 different formulations according to a pre-specified sequence during both Treatment Periods in the absence of esomeprazole, and the Treatment Periods in the presence of esomeprazole.	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.
Experimental: Part B; Study participants enrolled to this arm will receive pre-specified doses of UCB0599 or Placebo in a pre-specified sequence during the Treatment Period.	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: Placebo; Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B.; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax) of UCB0599 in Part A	Cmax = Maximum plasma concentration.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part A	AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part A	AUC(inf) = Area under the plasma concentration-time curve from time 0 to infinity.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part B	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.	From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) in Part B	A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events	From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part B	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.	From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
Maximum plasma concentration (Cmax) of UCB0599 in Part B	Cmax = Maximum plasma concentration.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part B	AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part B	AUC(inf) = Area under the plasma concentration-time curve from time 0 to infinity.	Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.	From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Percentage of study participants with serious treatment-emergent adverse events (TEAEs) in Part A	A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events	From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part A	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.	From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): April 13, 2024
• Study Completion (Actual): April 13, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; UCB0599; Healthy Study Participants; Bioavailability study
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: UP0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No