The purpose of the study is to evaluate the safety and tolerability after administration of multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in healthy study participants and participants with Parkinson's Disease (PD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
31
Up0077 102
Long Beach, California, United States
Up0077 103
Bay Harbor Islands, Florida, United States
Up0077 105
DeLand, Florida, United States
Up0077 107
Atlanta, Georgia, United States
Treatment-Emergent Adverse Avents (TEAEs) from Baseline to End of Study visit
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.
Time frame: From Baseline to End of study visit (up to Week 7)
Maximum observed plasma concentration (Cmax) in healthy participants on Day 1
Cmax: Maximum observed plasma concentration
Time frame: Day 1: Predose up to 12 hours post dose
Maximum observed plasma concentration (Cmax) in healthy participants on Day 28
Cmax: Maximum observed plasma concentration
Time frame: Day 28: Predose up to 24 hours post dose
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 1
Tmax: Time of observed Cmax
Time frame: Day 1: Predose up to 12 hours post dose
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 28
Tmax: Time of observed Cmax
Time frame: Day 28: Predose up to 24 hours post dose
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in healthy participants on Day 1
AUC(0-12h): Area under the curve from time 0 to 12 hours
Time frame: Day 1: Predose up to 12 hours post dose
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Up0077 101
Farmington Hills, Michigan, United States
Up0077 104
Raleigh, North Carolina, United States
Area under the concentration-time curve for the dosing interval (AUCtau) in healthy participants on Day 28
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Time frame: Day 28: Predose up to 24 hours post dose
Maximum observed plasma concentration (Cmax) in patients on Day 1
Cmax: Maximum observed plasma concentration
Time frame: Day 1: Predose up to 12 hours post dose
Maximum observed plasma concentration (Cmax) in patients on Day 28
Cmax: Maximum observed plasma concentration
Time frame: Day 28: Predose up to 24 hours post dose
Time to maximum observed plasma concentration (tmax) in patients on Day 1
Tmax: Time of observed Cmax
Time frame: Day 1: Predose up to 12 hours post dose
Time to maximum observed plasma concentration (tmax) in patients on Day 28
Tmax: Time of observed Cmax
Time frame: Day 28: Predose up to 24 hours post dose
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in patients on Day 1
AUC(0-12h): Area under the curve from time 0 to 12 hours
Time frame: Day 1: Predose up to 12 hours post dose
Area under the concentration-time curve for the dosing interval (AUCtau) in patients on Day 28
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Time frame: Day 28: Predose up to 24 hours post dose