UCB7853
DrugSubjects will receive UCB7853 at pre-specified time-points.
NCT Number: NCT04651153
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)
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Up0092 201, Leiden, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1 (healthy participants):
Part 2 (participants with Parkinson's Disease):
Exclusion criteria
Part 1 (healthy participants):
Part 2 (participants with Parkinson's Disease):
Subjects will receive UCB7853 at pre-specified time-points.
Subjects will receive Placebo at pre-specified time-points.
Time frame: From Day 1 to the End of Study Visit (Day 141), Part 1)
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
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: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
Cmax = Maximum observed concentration
Time frame: Samples will be taken from Day 57 to the End of Study Visit (Day 197), Part 2
Cmax = Maximum observed concentration
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
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) = 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
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
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
tmax = Time to reach Cmax
Time frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
t1/2 = Terminal half-life
Time frame: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CL = Total body clearance of the drug
Time frame: Samples will be taken from from Day 57 to Day 85, Part 2
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
Vz = Volume of distribution during terminal phase
Time frame: Day 7 (Part 1)
CSF = Cerebrospinal fluid
Time frame: Day 63 (Part 2)
CSF = Cerebrospinal fluid
UCB Biopharma SRL
Industry
A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients 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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