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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867642
• Other study ID #: UP0091
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: March 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

• Participants with Hoehn and Yahr Stages of 1 to 3 inclusive, (Hoehn and Yahr, 1967) at Screening when in the ON state

• Participants on stable dosage of all anti-Parkinsonian therapy for at least 30 days prior to first investigational medicinal product (IMP) administration (with the exception that MAO-B inhibitors that must be maintained at a stable level for at least 8 weeks prior), and it is anticipated that no changes will be needed during the course of the study

• Participant has a BP and HR at Screening, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 140 mmHg, mean diastolic BP ranging between 50 and 90 mmHg, and a mean HR between 50 and 90 bpm

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)

• Participant has a current history of alcohol or drug use disorder within the last Y Statistical Manual of Mental Disorders Version 5 (DSM-5), within the last year

• Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline

• Participant has the presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing

• Participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention

• Participant has a positive human immunodeficiency virus (HIV) antibody test

• Participant has clinical signs and symptoms consistent with COVID-19 or had a positive Sars-Cov-2 test result within the last 4 weeks prior to dosing

• Active treatment or a history of glaucoma

Part C only:

• Participant with implantable intracranial stimulator or history of intracranial surgery

• Participant with documented diagnosis of dementia or a Montreal Cognitive Assessment (MoCA) score <26 at screening

• Participant with history of psychotic symptoms (including significant hallucinations) requiring treatment with an antipsychotic medication within the 12 months prior to Admission

Related Conditions & MeSH terms

• Healthy Study Participants
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• UCB0022
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.

Other:
• Placebo
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.

Locations

Country	Name	City	State
United Kingdom	Up0091 001	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment-emergent adverse events (TEAEs)	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. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment.	From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C)
Secondary	Maximum plasma concentration (cmax) for each single dose of UCB0022 in Part A	Cmax: Maximum plasma concentration for each pre-specified single dose in Part A	From Day 1 (predose) at predefined time points (up to Day 3)
Secondary	Time to maximum plasma concentration (tmax) for each single dose of UCB0022 in Part A	tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A	From Day 1 (predose) at predefined time points (up to Day 3)
Secondary	Area under the plasma concentration-time curve from time zero to infinity (AUC) for a each dose of UCB0022 in Part A	AUC (AUCinfinity): Area under the UCB0022 plasma concentration-time curve from time zero to infinity for a each dose in Part A	From Day 1 (predose) at predefined time points (up to Day 3)
Secondary	Maximum plasma concentration during a dosing interval through steady state (Cmax, ss) for each dose UCB0022 in Part B and C	Cmax, ss: Maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C	From Day 1 (predose) at predefined time points (up to Day 16)
Secondary	Time to maximum plasma concentration during a dosing interval through steady state (tmax, ss) for each dose UCB0022 in Part B and C	tmax, ss: time to maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C	From Day 1 (predose) at predefined time points (up to Day 16)
Secondary	Area under the plasma concentration-time curve at steady state (AUCtau) on Day 1 for a each dose of UCB0022 in Part B and C	AUCtau: Area under the plasma concentration-time curve at steady state on Day 1 for a each dose of UCB0022 in Part B and C	From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
Secondary	Area under the plasma concentration-time curve at steady state (AUCtau) on Day 14 for a each dose of UCB0022 in Part B and C	AUCtau: Area under the plasma concentration-time curve at steady state on Day 14 for a each dose of UCB0022 in Part B and C	From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)