RecruitingPhase 1NCT07749768

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally as Single Ascending Doses With a Food-Effect Arm and Multiple Ascending Doses in Healthy Adult Participants, and as a Single Dose (Open-Label) in Patients With Active Ulcerative Colitis


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

90 participants

Start Date

Aug 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ONO-6414 and a drug called Placebo for people with ulcerative colitis (uc). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONO-6414

Administered orally

DRUGPlacebo

Administered orally


Locations(1)

Syneos Health Miami

Miami, Florida, United States

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NCT07749768


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