UP0091 1
London, United Kingdom
NCT Number: NCT04867642
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
London, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Not a woman of childbearing potential (WOCBP) as defined in the protocol OR A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment
Part C only:
Exclusion criteria
Part C only:
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B, C and D.
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other names: PBO
Time frame: From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C)
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. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment.
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
Cmax: Maximum plasma concentration for each pre-specified single dose in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
AUC (AUCinfinity): Area under the UCB0022 plasma concentration-time curve from time zero to infinity for a each dose in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 16)
Cmax, ss: Maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
Time frame: From Day 1 (predose) at predefined time points (up to Day 16)
tmax, ss: time to maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
Time frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
AUCtau: Area under the plasma concentration-time curve at steady state on Day 1 for a each dose of UCB0022 in Part B and C
Time frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
AUCtau: Area under the plasma concentration-time curve at steady state on Day 14 for a each dose of UCB0022 in Part B and C
UCB Biopharma SRL
Industry
A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease
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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