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

Trial Summary

What is the purpose of this trial?

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

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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