Glovadalen for Healthy Volunteers

Overseen By UCB Cares

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Disqualifiers: Cardiovascular, Liver disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new oral treatment called glovadalen (UCB0022). Researchers are testing it in healthy participants from Caucasian, Japanese, and Chinese backgrounds. The trial involves multiple doses to assess how the drug is absorbed and tolerated over time. It seeks healthy individuals with no major medical conditions who identify as Caucasian, Japanese, or Chinese based on family heritage. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand any specific requirements.

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

Research has shown that glovadalen (UCB0022) has been tested in both healthy individuals and those with Parkinson's disease. These studies found that glovadalen is generally safe and well-tolerated, without causing unexpected or serious side effects. This trial is in the early stages, focusing primarily on the treatment's safety for humans. Although early trials may not provide extensive data, the successful testing of glovadalen without major issues is promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about glovadalen (UCB0022) because it introduces a new approach to treatment through its unique multiple ascending dose design, which is not common in current options. Unlike standard treatments that often involve fixed doses, glovadalen's dosing strategy allows for gradual adjustments, potentially optimizing therapeutic effects while minimizing side effects. This innovative approach could offer a significant improvement in how effectively and safely conditions are managed, making it a promising option for future care.

What evidence suggests that glovadalen could be effective?

Research has shown that glovadalen (UCB0022) holds promise for improving movement problems. In studies with monkeys that mimic Parkinson's disease, glovadalen improved symptoms as effectively as levodopa, a common treatment, but with fewer severe side effects. This suggests that glovadalen might offer a new way to manage movement symptoms with potentially better tolerance. Although information from human studies remains limited, these results are encouraging for future treatments. Participants in this trial will receive multiple ascending doses of glovadalen or a matching placebo, depending on their assigned cohort. ^{1 2 4 6 7}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for healthy Caucasian, Japanese, and Chinese volunteers who meet the study's specific health requirements. The exact inclusion and exclusion criteria are not provided but typically involve factors like age range, general health status, and no current medications or conditions that could affect the outcome.

Inclusion Criteria

Japanese participants must be of Japanese descent and have not had a significant change in lifestyle or diet since leaving Japan

Chinese participants must be of Chinese descent and have not had a significant change in lifestyle or diet since leaving China

Caucasian participants must be of Caucasian descent

Exclusion Criteria

History of alcohol or drug use disorder within the last year

History of severe allergic reaction requiring medical intervention

Known hypersensitivity to study intervention components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of glovadalen or matching placebo at pre-specified time points

5 weeks

Multiple visits as per dosing schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• UCB0022

Trial Overview The study is testing the safety and tolerability of a new oral medication called glovadalen (UCB0022). Participants will either receive glovadalen or a placebo to compare effects. The pharmacokinetics—how the drug is processed in the body—will also be studied.

How Is the Trial Designed?

Group I: Cohort 3 (Chinese) Experimental Treatment 2 Interventions

Study participants randomized to Cohort 3 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period.

Group II: Cohort 2 (Japanese) Experimental Treatment 2 Interventions

Study participants randomized to Cohort 2 (Part B) will receive multiple ascending doses of glovadalen or matching PBO at pre-specified time points during the Treatment Period.

Group III: Cohort 1 (Caucasian) Experimental Treatment 2 Interventions

Study participants randomized to Cohort 1 (Part A) will receive multiple ascending doses of glovadalen (UCB0022) or matching placebo (PBO) at pre-specified time points during the Treatment Period.

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. ucb.com ucb.com/innovation/clinical-studies/clinical-studies-index/Glovadalen%20%28UCB0022%29

Glovadalen (UCB0022) A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease, Phase 1, UP0091

3. withpower.com withpower.com/trial/glovadalen-for-healthy-volunteers-0913f

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

4. delta.larvol.com delta.larvol.com/Products/?ProductId=6eaa30c3-0490-4078-9fb9-7c35cbd248d8

glovadalen (UCB0022) / UCB UCB0022 is a selective and potent D1PAM, able to improve motor disability in MPTP-treated macaques as effectively as levodopa, but with reduced severity of ...

5. apdaparkinson.org apdaparkinson.org/article/new-pd-treatments-clinical-trial-pipeline/

New Parkinson's Treatments in the Clinical Trial Pipeline This trial NCT05830396 is designed to evaluate the efficacy of ambroxol in patients with early-stage PD who carry a GBA gene mutation, a common ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06055985

NCT06055985 | A Study to Evaluate the Efficacy, Safety, ... They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...

7. go.drugbank.com go.drugbank.com/drugs/DB21709

Glovadalen: Uses, Interactions, Mechanism of Action Glovadalen is a small molecule drug. Glovadalen is under investigation in clinical trial NCT06970301 (A Study to Assess the Safety and ...