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COMPLETEDPHASE1

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease

A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease

NCT04867642•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant must be 18 to 55 years of age inclusive or 35 to 75 years for part C, at the time of signing the informed consent
•Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
•Study participant has a blood pressure (BP) and heart rate (HR) before the first dose, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 130 millimeters of mercury (mmHg), mean diastolic BP ranging between 50 and 80 mmHg, and mean HR between 45 and 90 beats per minute (bpm)
•Participant has a body weight of at least 45 kg and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive)
•Participants are male or female:
•A male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period
•A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
•Not a woman of childbearing potential (WOCBP) as defined in the protocol OR A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment
•Part C only:
•Patient must have a documented history of idiopathic Parkinson's disease confirmed by a neurologist, and with no other atypical or secondary parkinsonism (eg, multiple-system atrophy, progressive supranuclear palsy, or evidence of drug-induced parkinsonism)
+3 more criteria

Exclusion Criteria

•Participant has history or presence of cerebro/cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
•Participant has a high risk for cardiovascular accident based on family history or on laboratory test
•Participants with hypertension requiring medical treatment within 6 months before the Screening, or with clinically significant orthostatic hypotension
•Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
•Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
•Participant has active neoplastic disease or history within the past 5 years of screening visit except for basal cell or squamous epithelial carcinomas of the skin that have been treated with SOC. Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
•Participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing
•Participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing
•Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.0x upper limit of normal (ULN)
•Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
+11 more criteria

Locations (1)

UP0091 1

London, United Kingdom

Key Dates

Start Date

April 29, 2021

Primary Completion Date

February 27, 2023

Completion Date

February 27, 2023

Last Updated

November 18, 2025

Enrollment

100

ACTUAL participants

Conditions

Healthy Study ParticipantsParkinson's Disease

Interventions

UCB0022

DRUG

Placebo

OTHER

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations