The primary purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB7853 in healthy male study participants and to evaluate the safety and tolerability of multiple ascending doses of UCB7853 administered in study participants with Parkinson's Disease (PD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
62
Up0092 201
Leiden, Netherlands
Up0092 101
London, United Kingdom
Incidence of Treatment-emergent Adverse Events (TEAEs) in healthy male participants
A treatment-emergent Adverse Event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From Day 1 to the End of Study Visit (Day 141), Part 1)
Incidence of Treatment-emergent Adverse Events (TEAEs) in participants with Parkinson's Disease
A treatment-emergent Adverse Event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From Day 1 to the End of Study Visit (Day 197), Part 2
Cmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Cmax = Maximum observed concentration
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
Cmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
Cmax = Maximum observed concentration
Time frame: Samples will be taken from Day 57 to the End of Study Visit (Day 197), Part 2
AUC of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
AUC = Area under the concentration-time curve
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC(0-t) of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC(0-t) of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Time frame: Samples will be taken from Day 57 to Day 85, Part 2
tmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
tmax = Time to reach Cmax
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
tmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
tmax = Time to reach Cmax
Time frame: Samples will be taken from from Day 57 to the End of Study Visit (Day 197), Part 2
t1/2 of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
t1/2 = Terminal half-life
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of single ascending doses in healthy male participants
CL = Total body clearance of the drug
Time frame: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
CL = Total body clearance of the drug
Time frame: Samples will be taken from from Day 57 to Day 85, Part 2
Vz of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Vz = Volume of distribution during terminal phase
Time frame: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CSF/serum UCB7853 concentration ratio on Day 7 (Part 1)
CSF = Cerebrospinal fluid
Time frame: Day 7 (Part 1)
CSF/serum UCB7853 concentration ratio on Day 63 (Part 2)
CSF = Cerebrospinal fluid
Time frame: Day 63 (Part 2)