Up0135 1001
Glendale, California, 91206, United States
NCT Number: NCT06970301
The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Weight
Sex and contraceptive/barrier requirements
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
Study participants will receive doses of glovadalen (UCB0022) at pre-specified time points during the Treatment Period of Part A and Part B.
Other names: UCB0022
Study participants will receive matching placebo at pre-specified time points during the Treatment Period of Part A and Part B.
Other names: PBO
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.
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.
Time frame: Day 1 in Part A
Cmax: maximum observed plasma concentration
Time frame: From Day 10 to Day 37 in Part A
Cmax: maximum observed plasma concentration at steady state condition
Time frame: Day 1 in Part A
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours
Time frame: From Day 10 to Day 37 in Part A
AUC0-24,ss: area under the plasma concentration-time curve from time zero to 24 hours at steady state condition
Time frame: Day 1 in Part A
AUC0-t: area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: From Day 10 to Day 37 in 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: Day 1 in Part B
Cmax: maximum observed plasma concentration
Time frame: From Day 5 to Day 32 in Part B
Cmax: maximum observed plasma concentration at steady state condition
Time frame: Day 1 in Part B
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours
Time frame: From Day 5 to Day 32 in Part B
AUC0-24,ss: area under the plasma concentration-time curve from time zero to 24 hours at steady state condition
UCB Biopharma SRL
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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