Healthy Study ParticipantsPhase 1NCT06970301
A Study to Assess the Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants
A Phase 1 study testing glovadalen in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants
- What is being tested?
- glovadalen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 29 May 2026
- 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
- Healthy male and female participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests during the Screening Period. Participants with test results that are outside the specified normal ranges and that are deemed not clinically significant will be allowed at the discretion of the investigator. If participants have a test result outside the specific range that is deemed clinically significant, repeat of the investigation may be allowed at the discretion of the investigator.
- For Japanese participants: Participants are of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (participant have all 4 Japanese grandparents born in Japan) and have not had a significant change in lifestyle or diet since leaving Japan.
- For Chinese participants: Participants are of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China) and have not had a significant change in lifestyle or diet since leaving China.
- For Caucasian participants: Participants are of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent.
- Weight
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- Participants with body weight ≥45 kilogram (kg) and body mass index (BMI) within the range of 18.0 to 30.0 kg/m^2 (inclusive).
- Sex and contraceptive/barrier requirements
- Male and female
- Male participants must agree to use contraception of the full protocol during the Treatment Period and for 14 days after the final dose of study intervention and refrain from donating sperm during this period.
- Female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance of the full protocol during the Treatment Period and for at least 14 days after the final dose of study intervention
Who cannot join
- Participants have any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participants' ability to participate in this study.
- Participants have a 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; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator.
- History of hypertension, hypertensive crisis, hypertensive encephalopathy, or orthostatic hypotension, unless the underlying cause was unequivocally identified and has been removed.
- 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:
- aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN), (isolated bilirubin <1.5xULN is acceptable if fractionated and direct bilirubin <35%).
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- Tests that result in ALT, AST, bilirubin, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
- Participants have current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Participants have 12-lead ECG with changes considered to be clinically significant (eg, QTcF >450 ms in males and >470 ms in females based on average of triplicate ECGs, left bundle branch block, evidence of myocardial ischemia, or second-degree Type II atrioventricular block) during the Screening Period or Day -1.
- Participants have a history of risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- 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 a major organ transplant or hematopoietic stem cell/marrow transplant.
- Participants have a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders Version 5, within the last year.
- Participants have a known hypersensitivity to any components of the study intervention as stated in the protocol.
- Participants have a history of severe allergic reaction that required medical intervention.
- Participants have clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue, anosmia, ageusia) or had a positive SARS CoV 2 test result within the last 4 weeks prior to dosing.
- Active treatment or a history of glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Placebo-controlled, Participant-blind, Investigator-blind, Randomized, Multiple Ascending Dose in Titration Study to Assess The Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants
The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.
- Conditions
- Healthy Study Participants
- Being tested
- glovadalen, Placebo
- Keywords
- Healthy Study Participants, Phase 1, ascending dose, UCB0022, glovadalen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glovadalenDrug
Also called UCB0022
Study participants will receive doses of glovadalen (UCB0022) at pre-specified time points during the Treatment Period of Part A and Part B.
PlaceboOther
Also called PBO
Study participants will receive matching placebo at pre-specified time points during the Treatment Period of Part A and Part B.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Caucasian) | Experimental | Study participants randomized to Cohort 1 (Part A) will receive multiple ascending doses of glovadalen or matching placebo (PBO) at pre-specified time points during the Treatment Period. Receives: Drug: glovadalen; Other: Placebo |
| Cohort 2 (Japanese) | Experimental | Study participants randomized to Cohort 2 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period. Receives: Drug: glovadalen; Other: Placebo |
| Cohort 3 (Chinese) | Experimental | Study participants randomized to Cohort 3 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period. Receives: Drug: glovadalen; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of TEAEs (Part A)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Measured: From Baseline to the end of Safety Follow-up Period (up to 49 days)
Occurrence of TEAEs (Part B)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Measured: From Baseline to the end of Safety Follow-up Period (up to 44 days)
Secondary outcomes (10)
Cmax (Part A)
Cmax: maximum observed plasma concentration
Measured: Day 1 in Part A
Cmax,ss (Part A)
Cmax: maximum observed plasma concentration at steady state condition
Measured: From Day 10 to Day 37 in Part A
AUC0-24 (Part A)
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours
Measured: Day 1 in Part A
AUC0-24,ss (Part A)
AUC0-24,ss: area under the plasma concentration-time curve from time zero to 24 hours at steady state condition
Measured: From Day 10 to Day 37 in Part A
AUC0-t (Part A)
AUC0-t: area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Day 1 in Part A
AUC0-t,ss (Part A)
AUC0-t,ss: area under the plasma concentration-time curve from time zero to the last quantifiable concentration at steady state condition
Measured: From Day 10 to Day 37 in Part A
Cmax (Part B)
Cmax: maximum observed plasma concentration
Measured: Day 1 in Part B
Cmax,ss (Part B)
Cmax: maximum observed plasma concentration at steady state condition
Measured: From Day 5 to Day 32 in Part B
AUC0-24 (Part B)
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours
Measured: Day 1 in Part B
AUC0-24,ss (Part B)
AUC0-24,ss: area under the plasma concentration-time curve from time zero to 24 hours at steady state condition
Measured: From Day 5 to Day 32 in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start28 Apr 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Study ParticipantsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970301
- Sponsor's protocol ID
- UP0135
- Status last verified
- Jun 2026
- First submitted
- 12 May 2025
- Last updated
- 22 Jun 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 as 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Placebo-controlled, Participant-blind, Investigator-blind, Randomized, Multiple Ascending Dose in Titration Study to Assess The Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants
- ClinicalTrials.gov ID
- NCT06970301
- Acronym / sponsor ID
- UP0135
- Conditions
- Healthy Study Participants
- Keywords
- Healthy Study Participants, Phase 1, ascending dose, UCB0022, glovadalen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 14 May 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 primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Caucasian) | Experimental | Drug: glovadalen, Other: PlaceboStudy participants randomized to Cohort 1 (Part A) will receive multiple ascending doses of glovadalen or matching placebo (PBO) at pre-specified time points during the Treatment Period. |
| Cohort 2 (Japanese) | Experimental | Drug: glovadalen, Other: PlaceboStudy participants randomized to Cohort 2 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period. |
| Cohort 3 (Chinese) | Experimental | Drug: glovadalen, Other: PlaceboStudy participants randomized to Cohort 3 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF).
- Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests during the Screening Period. Participants with test results that are outside the specified normal ranges and that are deemed not clinically significant will be allowed at the discretion of the investigator. If participants have a test result outside the specific range that is deemed clinically significant, repeat of the investigation may be allowed at the discretion of the investigator.
- For Japanese participants: Participants are of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (participant have all 4 Japanese grandparents born in Japan) and have not had a significant change in lifestyle or diet since leaving Japan.
- For Chinese participants: Participants are of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China) and have not had a significant change in lifestyle or diet since leaving China.
- For Caucasian participants: Participants are of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent.
Key exclusion criteria (18 listed)
- Participants have any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participants' ability to participate in this study.
- Participants have a 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; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator.
- History of hypertension, hypertensive crisis, hypertensive encephalopathy, or orthostatic hypotension, unless the underlying cause was unequivocally identified and has been removed.
- 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 |
|---|---|---|
| glovadalenAlso: UCB0022Study participants will receive doses of glovadalen (UCB0022) at pre-specified time points during the Treatment Period of Part A and Part B. | Drug | Cohort 1 (Caucasian), Cohort 2 (Japanese), Cohort 3 (Chinese) |
| PlaceboAlso: PBOStudy participants will receive matching placebo at pre-specified time points during the Treatment Period of Part A and Part B. | Other | Cohort 1 (Caucasian), Cohort 2 (Japanese), Cohort 3 (Chinese) |
Primary outcome
Occurrence of TEAEs (Part A)
Time frame: From Baseline to the end of Safety Follow-up Period (up to 49 days)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Occurrence of TEAEs (Part B)
Time frame: From Baseline to the end of Safety Follow-up Period (up to 44 days)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
10 secondary outcomes
Cmax (Part A)
Time frame: Day 1 in Part A
Cmax,ss (Part A)
Time frame: From Day 10 to Day 37 in Part A
AUC0-24 (Part A)
Time frame: Day 1 in Part A
AUC0-24,ss (Part A)
Time frame: From Day 10 to Day 37 in Part A
AUC0-t (Part A)
Time frame: Day 1 in Part A
AUC0-t,ss (Part A)
Time frame: From Day 10 to Day 37 in Part A
Cmax (Part B)
Time frame: Day 1 in Part B
Cmax,ss (Part B)
Time frame: From Day 5 to Day 32 in Part B
AUC0-24 (Part B)
Time frame: Day 1 in Part B
AUC0-24,ss (Part B)
Time frame: From Day 5 to Day 32 in Part B
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 22 Jun 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as 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
001 844 599 2273
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 glovadalen in people with Healthy Study Participants, 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 12 inclusion and 18 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 22 Jun 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?
Occurrence of TEAEs (Part A) (time frame: From Baseline to the end of Safety Follow-up Period (up to 49 days)). The study lists 2 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 22 Jun 2026.