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NCT05845645 · ClinicalTrials.gov registry record · Phase 1
A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharmacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B
A Phase 1 study, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT05845645: Completed Phase 1 study, sponsored by UCB Biopharma SRL.
NCT05845645 is a Phase 1 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05845645, a Phase 1 study, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).
Primary Outcome
Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599 under normal and elevated gastric pH condition.
Interventions
- OTHER Placebo
- DRUG UCB0599
- OTHER Esomeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2024-04-13 |
| Phase | Phase 1 |
What the finished NCT05845645 record still lists
NCT05845645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05845645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05845645 about?
NCT05845645 is a clinical study titled "A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharmacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B". The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese or...
What is the current status of trial NCT05845645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2023-05-31. Estimated completion is 2024-04-13.
What interventions are being tested in trial NCT05845645?
The interventions under investigation include: Placebo (OTHER), UCB0599 (DRUG), Esomeprazole (OTHER).
Who is sponsoring clinical trial NCT05845645?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05845645's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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