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

Part of paid clinical trials in Miami, Florida.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT07749768
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ONO-6414 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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).

Key Dates

First listed
Aug 6, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: ONO-6414: Single ascending dose
    Single ascending dose: Participants will receive a single dose of ONO-6414 orally on Day 1.
  • Experimental: ONO-6414: Multiple ascending dose
    Multiple ascending dose: Participants will receive ONO-6414 orally for 7 consecutive days.
  • Experimental: ONO-6414: Single dose
    Single dose: Participants will receive a single dose of ONO-6414 orally on Day 1.

Primary Outcome Measure

Safety and tolerability: Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 168 hours post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos Health MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By research site
Syneos Health Miami· Miami, FL

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