A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)

Sponsor

UCB Biopharma S.P.R.L. (Industry)

Overall Status

Completed

CT.gov ID

NCT04875962

Collaborator

(none)

Enrollment

Locations

Arms

9.5

Actual Duration (Months)

5.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: UCB0599 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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)

Actual Study Start Date :

May 6, 2019

Actual Primary Completion Date :

Feb 19, 2020

Actual Study Completion Date :

Feb 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 - UCB0599 Participants will be randomized to receive a predefined dosage of UCB0599.	Drug: UCB0599 Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
Experimental: Cohort 2 - UCB0599 Participants will be randomized to receive a predefined dosage of UCB0599.	Drug: UCB0599 Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
Placebo Comparator: Cohort 1 - Placebo Participants will be randomized to receive a predefined dosage of Placebo.	Drug: Placebo Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.
Placebo Comparator: Cohort 2 - Placebo Participants will be randomized to receive a predefined dosage of Placebo.	Drug: Placebo Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.

Outcome Measures

Primary Outcome Measures

Treatment-Emergent Adverse Avents (TEAEs) from Baseline to End of Study visit [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.

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) in healthy participants on Day 1 [Day 1: Predose up to 12 hours post dose]
Cmax: Maximum observed plasma concentration
Maximum observed plasma concentration (Cmax) in healthy participants on Day 28 [Day 28: Predose up to 24 hours post dose]
Cmax: Maximum observed plasma concentration
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 1 [Day 1: Predose up to 12 hours post dose]
Tmax: Time of observed Cmax
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 28 [Day 28: Predose up to 24 hours post dose]
Tmax: Time of observed Cmax
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in healthy participants on Day 1 [Day 1: Predose up to 12 hours post dose]
AUC(0-12h): Area under the curve from time 0 to 12 hours
Area under the concentration-time curve for the dosing interval (AUCtau) in healthy participants on Day 28 [Day 28: Predose up to 24 hours post dose]
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Maximum observed plasma concentration (Cmax) in patients on Day 1 [Day 1: Predose up to 12 hours post dose]
Cmax: Maximum observed plasma concentration
Maximum observed plasma concentration (Cmax) in patients on Day 28 [Day 28: Predose up to 24 hours post dose]
Cmax: Maximum observed plasma concentration
Time to maximum observed plasma concentration (tmax) in patients on Day 1 [Day 1: Predose up to 12 hours post dose]
Tmax: Time of observed Cmax
Time to maximum observed plasma concentration (tmax) in patients on Day 28 [Day 28: Predose up to 24 hours post dose]
Tmax: Time of observed Cmax
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in patients on Day 1 [Day 1: Predose up to 12 hours post dose]
AUC(0-12h): Area under the curve from time 0 to 12 hours
Area under the concentration-time curve for the dosing interval (AUCtau) in patients on Day 28 [Day 28: Predose up to 24 hours post dose]
AUCtau: Area under the concentration-time curve for the dosing interval at steady state

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent
Study participant with Parkinson's disease (PD) must have a clinical diagnosis of PD. The following diagnostic criteria must be met: Bradykinesia AND at least ONE of the following: muscular rigidity or resting tremor
Study participant with PD must have a historic brain image (magnetic resonance imaging (MRI) or computerized tomography (CT) obtained at any point from the time of clinical diagnosis to the time of Screening that does not show any brain abnormalities that could cause symptomatic Parkinsonism
Study participant must have a Hoehn and Yahr Stage: 1 to 3
Study participant must be either untreated, or treated with a stable regimen (at least 4 weeks prior to Baseline Visit) of antiparkinsonian drugs and is expected to remain on this regimen for the duration of the study
Body weight >50 kg (110 lbs) and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)

Exclusion Criteria:

Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
Study participant has a known relevant allergy, a pre-existing history of a relevant allergic condition, or a predisposition for an allergic reaction (ie, total immunoglobulin E [IgE] value above normal range at Screening); this study participant's inclusion should be discussed with the Medical Monitor
Study participant has a history of levodopa-induced motor fluctuations or dyskinesia expected to interfere with his/her ability to participate in the study
Study participant has ongoing significant inflammatory gastrointestinal disorders and/or clinical signs of significant gastrointestinal problems at Screening
Study participant has a historic brain scan (MRI scan or CT scan) or an MRI scan performed at Screening indicative of a clinically significant abnormality
Study participant has a diagnosis of a significant Central nervous system (CNS) disease other than PD or history of epilepsy or seizure disorder other than febrile seizures as a child
Abnormalities in lumbar spine previously known or determined by a screening lumbar x-ray (if conducted)
History of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose participant to complications or technical difficulty with lumbar puncture
Evidence or history of significant active bleeding or coagulation disorder or use of drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Study participant has a history or present condition of respiratory or cardiovascular disorders at Screening (eg, cardiac insufficiency, coronary heart disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) which is considered clinically significant by the Investigator
Study participant has medical history or current diagnosis of diabetes
Study participant has clinical significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator
Study participant has had prior treatment with an investigational vaccine for PD (including active immunization or passive immunotherapy with monoclonal antibodies)
Study participant has had prior surgical treatment of PD involving intracranial surgery or implantation of a device (including deep brain stimulation) or duodopa

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Up0077 102	Long Beach	California	United States	90806
2	Up0077 103	Bay Harbor Islands	Florida	United States	33154
3	Up0077 105	DeLand	Florida	United States	32720
4	Up0077 107	Atlanta	Georgia	United States	30331
5	Up0077 101	Farmington Hills	Michigan	United States	48334
6	Up0077 104	Raleigh	North Carolina	United States	27612