Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glovadalen | Drug | Study participants will receive doses of glovadalen (UCB0022) at pre-specified time points during the Treatment Period of Part A and Part B. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Baseline to the end of Safety Follow-up Period (up to 44 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Part A) | Cmax: maximum observed plasma concentration | Day 1 in Part A |
| Cmax,ss (Part A) | Cmax: maximum observed plasma concentration at steady state condition |
Not provided
Inclusion Criteria:
Weight
- 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
Exclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0135 1001 | Glendale | California | 91206 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a participant- and investigator-blind study.
|
| Placebo | Other | Study participants will receive matching placebo at pre-specified time points during the Treatment Period of Part A and Part B. |
|
|
| 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 | 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 | 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 | 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 | From Day 10 to Day 37 in Part A |
| Cmax (Part B) | Cmax: maximum observed plasma concentration | Day 1 in Part B |
| Cmax,ss (Part B) | Cmax: maximum observed plasma concentration at steady state condition | 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 | 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 | From Day 5 to Day 32 in Part B |