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

Sponsor

UCB Biopharma SRL (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05845645

Collaborator

(none)

Enrollment

Arms

6.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal 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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Study Participants	Drug: UCB0599 Other: Esomeprazole Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Part A of the study is following a full crossover design and Part B is a parallel design with crossover character referring to the dose levels.Part A of the study is following a full crossover design and Part B is a parallel design with crossover character referring to the dose levels.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Part A is open-label and Part B double-blind (Participants will be blinded to the treatment (ie, UCB0599 or Placebo), but not to the dosage).

Primary Purpose:

Basic Science

Official Title:

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)

Anticipated Study Start Date :

May 18, 2023

Anticipated Primary Completion Date :

Nov 19, 2023

Anticipated Study Completion Date :

Nov 19, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) of UCB0599 in Part A [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
Cmax = Maximum plasma concentration.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part A [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration.
Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part A [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
AUC(inf) = Area under the plasma concentration-time curve from time 0 to infinity.
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part B [From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)]
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.
Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) in Part B [From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)]
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
Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part B [From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)]
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.
Maximum plasma concentration (Cmax) of UCB0599 in Part B [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
Cmax = Maximum plasma concentration.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part B [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration.
Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part B [Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)]
AUC(inf) = Area under the plasma concentration-time curve from time 0 to infinity.

Secondary Outcome Measures

Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A [From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)]
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.
Percentage of study participants with serious treatment-emergent adverse events (TEAEs) in Part A [From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)]
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
Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part A [From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UCB Biopharma SRL

ClinicalTrials.gov Identifier:

NCT05845645

Other Study ID Numbers:

UP0073

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by UCB Biopharma SRL

Phase 1

Healthy Study Participants

UCB0599

Bioavailability study

Additional relevant MeSH terms:

Esomeprazole

Study Results

No Results Posted as of May 6, 2023