A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis (NCT07749768)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Syneos Health Miami — Miami, Florida
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Syneos Health Miami — Miami, Florida
📞 Contact the Study Coordinator
Phone: (866) 587-7745
Email: clinical_trial@ono-pharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis (UC)
- Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants — Miami, Florida
- A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC) — Birmingham, Alabama
- A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis — Coronado, California
- A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) — Mobile, Alabama
- Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy — Kelowna, British Columbia
Explore by condition: All Ulcerative Colitis (UC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.