UCB0599
DrugParticipants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
NCT Number: NCT04875962
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).
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Notify Me40 year–80 year
All sexes
Interventional
Phase 1
Up0077 102, Long Beach, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.
Time frame: From Baseline to End of study visit (up to Week 7)
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: Day 1: Predose up to 12 hours post dose
Cmax: Maximum observed plasma concentration
Time frame: Day 28: Predose up to 24 hours post dose
Cmax: Maximum observed plasma concentration
Time frame: Day 1: Predose up to 12 hours post dose
Tmax: Time of observed Cmax
Time frame: Day 28: Predose up to 24 hours post dose
Tmax: Time of observed Cmax
Time frame: Day 1: Predose up to 12 hours post dose
AUC(0-12h): Area under the curve from time 0 to 12 hours
Time frame: Day 28: Predose up to 24 hours post dose
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Time frame: Day 1: Predose up to 12 hours post dose
Cmax: Maximum observed plasma concentration
Time frame: Day 28: Predose up to 24 hours post dose
Cmax: Maximum observed plasma concentration
Time frame: Day 1: Predose up to 12 hours post dose
Tmax: Time of observed Cmax
Time frame: Day 28: Predose up to 24 hours post dose
Tmax: Time of observed Cmax
Time frame: Day 1: Predose up to 12 hours post dose
AUC(0-12h): Area under the curve from time 0 to 12 hours
Time frame: Day 28: Predose up to 24 hours post dose
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
UCB Biopharma S.P.R.L.
Industry
A Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
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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