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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
Study participants will receive doses of glovadalen (UCB0022) at pre-specified time points during the Treatment Period of Part A and Part B.
Study participants will receive matching placebo at pre-specified time points during the Treatment Period of Part A and Part B.
Up0135 1001
Glendale, California, United States
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.
Time frame: 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.
Time frame: From Baseline to the end of Safety Follow-up Period (up to 44 days)
Cmax (Part A)
Cmax: maximum observed plasma concentration
Time frame: Day 1 in Part A
Cmax,ss (Part A)
Cmax: maximum observed plasma concentration at steady state condition
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: From Day 10 to Day 37 in Part A
Cmax (Part B)
Cmax: maximum observed plasma concentration
Time frame: Day 1 in Part B
Cmax,ss (Part B)
Cmax: maximum observed plasma concentration at steady state condition
Time frame: 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
Time frame: 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
Time frame: From Day 5 to Day 32 in Part B