Healthy VolunteersPhase 1NCT07220551
A Phase 1 Relative Bioavailability Study of UCB0022 Tablets in Healthy Participants
A Phase 1 study testing UCB0022 in people with Healthy Volunteers, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in healthy participants following single oral administration. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- UCB0022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 16 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be minimum 18 years and maximum 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants have a blood pressure (BP) and heart rate (HR) during the Screening Period or before the first dose of study intervention, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90mmHg and 130mmHg, mean diastolic BP ranging between 50mmHg and 80mmHg, and mean HR between 45bpm and 90bpm.
- Body weight greater than or equal (≥)45 kilograms (kg) and body mass index within the range 18.0 kilograms per meter square (kg/m2) to 30.0 kg/m2 (inclusive).
- A male participant must agree to use contraception during both Periods and for at least 14 days after the final dose of study intervention, and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
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- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during both Periods and for at least 14 days after the final dose of study intervention.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Who cannot join
- Participants have 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.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- History of hypertension, hypertensive crisis, hypertensive encephalopathy, or orthostatic hypotension
- History of ischemic stroke, transient ischemic attack, angina, myocardial infarction, any systemic embolism, any clinically significant arrythmia, or congestive heart failure.
- Participants have the following liver enzyme test results during the Screening Period or Day -1:
- alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0×upper limit of normal (ULN) (isolated bilirubin <1.5×ULN is acceptable if fractionated and direct bilirubin <35%).
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- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Participants have 12-lead electrocardiogram (ECG) with changes considered to be clinically significant (eg, QTcF >450ms in males and >470ms in females , left bundle branch block, evidence of myocardial ischemia, or second-degree Type II atrioventricular block).
- Participants have a history of risk factors for torsades de pointes.
- Participants have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Participants have had breast cancer within the past 10 years.
- Participants have a history of severe allergic reaction that required medical intervention.
- Participants have a positive HBsAg, hepatitis C virus antibody, or human immunodeficiency virus 1 and 2 antibody result at the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Center, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability and Safety of Two UCB0022 Tablet Formulations in Healthy Participants
The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in healthy participants following single oral administration.
- Conditions
- Healthy Volunteers
- Being tested
- UCB0022
- Keywords
- Healthy Volunteers;, UCB0022;, Glovadalen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0022Drug
Also called Glovadalen
Participants will receive a single oral dose of UCB0022 tablet Formulation 1 and UCB0022 tablet Formulation 2 following a pre-specified sequence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Study participants will receive a single oral dose of UCB0022 Formulation 1 (reference) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 2 (test) on Day 15 (dosing day of Period 2) in Treatment sequence A-B.
A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. Receives: Drug: UCB0022 |
| Treatment Sequence BA | Experimental | Study participants will receive a single oral dose of UCB0022 Formulation 2 (test) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 1 (reference) on Day 15 (dosing day of Period 2) in Treatment sequence B-A.
A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. Receives: Drug: UCB0022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve of UCB0022
AUC: Area under the plasma concentration-time curve.
Measured: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
Area under the plasma concentration-time curve from time 0 to t of UCB0022
AUC0-t: Area under the plasma concentration-time curve from time 0 to t.
Measured: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
Maximum observed plasma concentration of UCB0022
Cmax: Maximum observed plasma concentration.
Measured: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
Secondary outcomes (1)
Occurrence of Treatment-emertgent Adverse Events (TEAEs) from Day 1 up to end of the Safety Follow-up (SFU) Period or End of Study (EOS)
A TEAE is defined as any AE with a start date or time on or after the first dose of study intervention until the end of the SFU Period (ie, EOS/SFU Visit).
Measured: From Dosing (Day 1) up to SFU period or End of study (EOS) (up to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start23 Oct 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 0018445992273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220551
- Sponsor's protocol ID
- UP0159
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, individual patient-level data 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability and Safety of Two UCB0022 Tablet Formulations in Healthy Participants
- ClinicalTrials.gov ID
- NCT07220551
- Acronym / sponsor ID
- UP0159
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers;, UCB0022;, Glovadalen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in healthy participants following single oral administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: UCB0022Study participants will receive a single oral dose of UCB0022 Formulation 1 (reference) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 2 (test) on Day 15 (dosing day of Period 2) in Treatment sequence A-B. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. |
| Treatment Sequence BA | Experimental | Drug: UCB0022Study participants will receive a single oral dose of UCB0022 Formulation 2 (test) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 1 (reference) on Day 15 (dosing day of Period 2) in Treatment sequence B-A. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participant must be minimum 18 years and maximum 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants have a blood pressure (BP) and heart rate (HR) during the Screening Period or before the first dose of study intervention, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90mmHg and 130mmHg, mean diastolic BP ranging between 50mmHg and 80mmHg, and mean HR between 45bpm and 90bpm.
- Body weight greater than or equal (≥)45 kilograms (kg) and body mass index within the range 18.0 kilograms per meter square (kg/m2) to 30.0 kg/m2 (inclusive).
- A male participant must agree to use contraception during both Periods and for at least 14 days after the final dose of study intervention, and refrain from donating sperm during this period.
Key exclusion criteria (13 listed)
- Participants have 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.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- History of hypertension, hypertensive crisis, hypertensive encephalopathy, or orthostatic hypotension
- History of ischemic stroke, transient ischemic attack, angina, myocardial infarction, any systemic embolism, any clinically significant arrythmia, or congestive heart failure.
- Participants have the following liver enzyme test results during the Screening Period or Day -1:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB0022Also: GlovadalenParticipants will receive a single oral dose of UCB0022 tablet Formulation 1 and UCB0022 tablet Formulation 2 following a pre-specified sequence. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Area under the plasma concentration-time curve of UCB0022
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
AUC: Area under the plasma concentration-time curve.
Area under the plasma concentration-time curve from time 0 to t of UCB0022
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
AUC0-t: Area under the plasma concentration-time curve from time 0 to t.
Maximum observed plasma concentration of UCB0022
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
Cmax: Maximum observed plasma concentration.
1 secondary outcome
Occurrence of Treatment-emertgent Adverse Events (TEAEs) from Day 1 up to end of the Safety Follow-up (SFU) Period or End of Study (EOS)
Time frame: From Dosing (Day 1) up to SFU period or End of study (EOS) (up to Day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, individual patient-level data 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
0018445992273
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB0022 in people with Healthy Volunteers, run by UCB Biopharma SRL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve of UCB0022 (time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.