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UCB0599 + Esomeprazole for Healthy Volunteers

Phase 1

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) to safety follow-up period of part a (up to day 39)

Awards & highlights

Study Summary

This trial tests a new drug's safety, effectiveness, and how it is processed in healthy people of Japanese and Chinese origin.

Who is the study for?

This trial is for healthy volunteers, including those of Japanese and Chinese descent with specific body weight and BMI criteria. Participants must not have significant medical conditions or a history of certain cancers. They should not be on other clinical trials, consume large amounts of caffeine, or have had grapefruit recently.Check my eligibility

What is being tested?

The study tests the bioavailability (how well the body absorbs) two new formulations of UCB0599 under different stomach pH levels in Part A. In Part B, it assesses safety, tolerability, and how the drug moves through the bodies (pharmacokinetics) of healthy Japanese and Chinese participants.See study design

What are the potential side effects?

While this study primarily focuses on healthy individuals to test bioavailability and pharmacokinetics rather than side effects directly, potential risks may include allergic reactions to components in UCB0599 or mild gastrointestinal disturbances as commonly seen with oral medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) to safety follow-up period of part a (up to day 39)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) to safety follow-up period of part a (up to day 39)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to safety follow-up period of part a (up to day 39) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part A

Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part B

Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part A

+6 more

Secondary outcome measures

Percentage of study participants with serious treatment-emergent adverse events (TEAEs) in Part A

Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A

Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part A

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment2 Interventions

Study participants enrolled to this arm will receive pre-specified doses of UCB0599 or Placebo in a pre-specified sequence during the Treatment Period.

Group II: Part AExperimental Treatment2 Interventions

Study participants enrolled and randomized to this arm will receive a single dose of UCB0599 in 3 different formulations according to a pre-specified sequence during both Treatment Periods in the absence of esomeprazole, and the Treatment Periods in the presence of esomeprazole.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UCB0599

2019

Completed Phase 1

~40

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,364 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,891 Total Patients Enrolled

Media Library

Healthy Volunteers Research Study Groups: Part A, Part B

Healthy Volunteers Clinical Trial 2023: UCB0599 Highlights & Side Effects. Trial Name: NCT05845645 — Phase 1

UCB0599 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05845645 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Part A of this product been approved by the FDA?

"Due to the limited data available on Part A's safety and efficacy, our team of Power experts has rated its security as a 1."

Answered by AI

Are there still openings available in this research program?

"According to the details posted on clinicaltrials.gov, participants are currently being sought out for this medical experiment. It was originally advertised on May 31st 2023 and its information has been updated most recently on June 26th of the same year."

Answered by AI

How many participants have been approved to partake in this experiment?

"Affirmative. The clinicaltrial.gov website attests to the fact that this medical trial, which was initially posted on May 31st 2023, is currently enrolling participants. 72 hopeful patients must be enlisted from 1 different clinic location."

Answered by AI

Is the participant criteria for this trial limited to individuals aged 60 and over?

"The age restrictions for this medical trial stipulate that patients must be 18 years old or older and no more than 55 to participate."

Answered by AI

Am I qualified to join this scientific experiment?

"Potentially eligible applicants must be healthy volunteers between the ages of 18 and 55. This clinical trial is accepting a total of 72 people for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharamacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B

2023. "A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharamacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05845645.

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