UCB0022 for Healthy Volunteers
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single oral dose of UCB0022 Formulation 1 or 2
Washout
A washout period for elimination of the drug between administrations
Treatment Period 2
Participants receive a single oral dose of the alternate UCB0022 formulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- UCB0022
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
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