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 | Completed Phase 1 Results FDA Drug

• 1 other identifier: UP0073
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phase 1; Healthy Study Participants; UCB0599; Bioavailability study

Outcome Measures

Primary Outcomes (9)

• Maximum Plasma Concentration (Cmax) of UCB0599 in Part A

  Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599 under normal and elevated gastric pH condition.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A

• 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) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599 under normal and elevated gastric pH condition.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A

• Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A

  AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599 under normal and elevated gastric pH condition.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A

• Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B

  An AE was 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. A TEAE was defined as AEs starting on/after the date/time of first treatment \& upto including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment.

  From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)

• Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B

  Serious TEAEs were any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment and additionally were emergent untoward medical occurrence that at any dose: 1. Results in death 2. Is life-threatening 3. Required in patient hospitalisation or prolongation of existing hospitalisation 4. Results in persistent disability/incapacity 5. Was a congenital anomaly or birth defect 6. Important medical events

  From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)

• Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B

  : An AE was 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. A TEAE was defined as AEs starting on/after the date/time of first treatment \& upto including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment.

  From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)

• Maximum Plasma Concentration (Cmax) of UCB0599 in Part B

  Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B

• 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) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B

• Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B

  AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599.

  Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Part A

EXPERIMENTAL

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; Other: Esomeprazole

Part B

EXPERIMENTAL

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; Other: Placebo

Interventions

UCB0599 DRUG

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

Part A; Part B

Esomeprazole OTHER

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.

Part A

Placebo OTHER

Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B.

Also known as: PBO

Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0073 10001

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: May 31, 2023
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)