Trials / Completed
CompletedNCT05507515
A Phase 1 Study of ONO-2020 in Healthy Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Five-part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of ONO-2020 in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-2020 | ONO-2020 tablets |
| DRUG | Placebo | Placebo tablets matching ONO-2020 tablets |
Timeline
- Start date
- 2022-07-29
- Primary completion
- 2023-12-24
- Completion
- 2023-12-24
- First posted
- 2022-08-19
- Last updated
- 2024-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05507515. Inclusion in this directory is not an endorsement.