UCB0022 for Healthy Volunteers

Overseen By UCB Cares

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Disqualifiers: Cardiovascular, Respiratory, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two formulations of the drug UCB0022 to determine how the body absorbs each one. The researchers aim to identify which formulation is more readily available in the body after oral administration. As a Phase 1 trial, the focus is on safety and understanding the drug's behavior in healthy individuals. It suits those who are generally healthy, with normal blood pressure and heart rates, and without major medical conditions. Participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy volunteers, it is likely that participants should not be on any regular medications that could affect the study results.

Is there any evidence suggesting that UCB0022 is likely to be safe for humans?

Research shows that UCB0022 has been tested for safety in both healthy individuals and those with Parkinson's Disease. In these studies, UCB0022 was generally well-tolerated. Some participants reported mild side effects, but no major safety concerns emerged.

These studies are in the early stages, so the long-term effects remain unknown. However, current information suggests that UCB0022 is safe for humans, at least in the short term. For those considering joining a trial, this indicates that the treatment has undergone sufficient testing to suggest its safety for further study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about UCB0022 because it introduces a novel approach to treatment through its two distinct formulations. Unlike other treatments, which might use a single formulation or delivery method, UCB0022 offers two oral formulations that are being tested for effectiveness and safety. This dual-formulation strategy could potentially improve patient outcomes by optimizing how the drug is absorbed and utilized in the body. While the exact mechanism of action is still under investigation, the flexibility in formulation might offer a tailored approach, enhancing the drug's effectiveness and minimizing side effects compared to current options.

What evidence suggests that this trial's treatments could be effective?

Researchers are currently studying UCB0022 to understand how the body absorbs and processes the drug. The trial involves healthy volunteers receiving different formulations of UCB0022 in separate treatment sequences. This approach helps researchers understand its potential for treating illnesses in the future. Early research indicates that UCB0022 can be safe and well-tolerated by various groups, including individuals with Parkinson's Disease. ^{1 2 3 6 7}

Who Is on the Research Team?

UCB Cares

Principal Investigator

0018445992273

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can safely take part in a study to compare two different forms of a new medication called UCB0022 after taking it just once.

Inclusion Criteria

Participants have a blood pressure (BP) and heart rate (HR) during the Screening Period or before the first dose of study intervention, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90mmHg and 130mmHg, mean diastolic BP ranging between 50mmHg and 80mmHg, and mean HR between 45bpm and 90bpm.

I am not pregnant or breastfeeding and either cannot become pregnant or agree to follow birth control guidelines.

I am generally healthy as confirmed by recent medical exams and tests.

Exclusion Criteria

Participants have any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.

Participants have 12-lead electrocardiogram (ECG) with changes considered to be clinically significant (eg, QTcF >450ms in males and >470ms in females , left bundle branch block, evidence of myocardial ischemia, or second-degree Type II atrioventricular block).

I have risk factors for a specific heart rhythm problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive a single oral dose of UCB0022 Formulation 1 or 2

14 days

1 visit (in-person)

Washout

A washout period for elimination of the drug between administrations

14 days

Treatment Period 2

Participants receive a single oral dose of the alternate UCB0022 formulation

14 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 days

What Are the Treatments Tested in This Trial?

Interventions

• UCB0022

Trial Overview

The study aims to understand how the body absorbs and processes two formulations of UCB0022 by comparing Formulation 2 (the test) with Formulation 1 (the reference) after a single dose.

How Is the Trial Designed?

Group I: Treatment Sequence BA Experimental Treatment 1 Intervention

Study participants will receive a single oral dose of UCB0022 Formulation 2 (test) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 1 (reference) on Day 15 (dosing day of Period 2) in Treatment sequence B-A. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2.

Group II: Treatment Sequence AB Experimental Treatment 1 Intervention

Study participants will receive a single oral dose of UCB0022 Formulation 1 (reference) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 2 (test) on Day 15 (dosing day of Period 2) in Treatment sequence A-B. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06970301

NCT06970301 | A Study to Assess the Safety and ...

The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants ...

2.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-f9461

UCB0022 for Healthy Volunteers · Info for Participants

The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in ...

3.

ucb.com

ucb.com/innovation/clinical-studies/clinical-studies-index/UCB0022

UCB0022

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

4.

evergreenhealth.com

evergreenhealth.com/health-services/clinical-trials/find-a-clinical-trial/details/?id=55

A Study to Evaluate the Efficacy, Safety, Tolerability, and ...

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC)

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06055985

NCT06055985 | A Study to Evaluate the Efficacy, Safety, ...

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC)

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-test-the-safety-tolerability-and-blood-levels-of-ucb0022-in-healthy-participants-and-pa

A Study to Test the Safety, Tolerability, and Blood Levels of ...

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

7.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT04867642/

Trial | NCT04867642

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