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NCT05507515 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of ONO-2020 in Healthy Participants
A Phase 1 study, sponsored by Ono Pharmaceutical Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT05507515: Completed Phase 1 study, sponsored by Ono Pharmaceutical Co..
NCT05507515 is a Phase 1 study that has completed, run by Ono Pharmaceutical Co.. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05507515, a Phase 1 study, has completed, sponsored by Ono Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants. This FIH study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, as well as the food effect on the PK of ONO-2020. These data will support the clinical development program and help inform dose selection in future studies.
Primary Outcome
Incidence of TEAEs will be summarized overall, and by study part and dose group using frequency and percentage.
Interventions
- DRUG Placebo
- DRUG ONO-2020
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-07-29 |
| Est. Completion | 2023-12-24 |
| Phase | Phase 1 |
What the finished NCT05507515 record still lists
NCT05507515 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05507515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05507515 about?
NCT05507515 is a clinical study titled "A Phase 1 Study of ONO-2020 in Healthy Participants". The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants. This FIH study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, ...
What is the current status of trial NCT05507515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2022-07-29. Estimated completion is 2023-12-24.
What interventions are being tested in trial NCT05507515?
The interventions under investigation include: Placebo (DRUG), ONO-2020 (DRUG).
Who is sponsoring clinical trial NCT05507515?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05507515's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 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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