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 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ONO-6414-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ulcerative Colitis (UC)

Keywords

ONO-6414-01; ONO-6414; ulcerative colitis

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability: Number of Participants with Adverse Events (AEs)

  All parts

  Up to 168 hours post-dose

• Pharmacokinetic parameter of ONO-6414: Cmax

  All parts

  Predose and up to 72 hours post-dose

• Pharmacokinetic parameter of ONO-6414: Tmax

  All parts

  Predose and up to 72 hours post-dose

• Pharmacokinetic parameter of ONO-6414: AUC

  All parts

  Predose and up to 72 hours post-dose

• Plasma concentration of ONO-6414

  All parts

  Predose and up to 72 hours post-dose

Secondary Outcomes (2)

• Effect of food on Cmax of ONO-6414

  Predose and up to 72 hours post-dose

• Effect of food on AUClast of ONO-6414

  Predose and up to 72 hours post-dose

Study Arms (3)

ONO-6414: Single ascending dose

EXPERIMENTAL

Single ascending dose: Participants will receive a single dose of ONO-6414 orally on Day 1.

Drug: ONO-6414; Drug: Placebo

ONO-6414: Multiple ascending dose

EXPERIMENTAL

Multiple ascending dose: Participants will receive ONO-6414 orally for 7 consecutive days.

Drug: ONO-6414; Drug: Placebo

ONO-6414: Single dose

EXPERIMENTAL

Single dose: Participants will receive a single dose of ONO-6414 orally on Day 1.

Drug: ONO-6414

Interventions

ONO-6414 DRUG

Administered orally

ONO-6414: Multiple ascending dose; ONO-6414: Single ascending dose; ONO-6414: Single dose

Placebo DRUG

Administered orally

ONO-6414: Multiple ascending dose; ONO-6414: Single ascending dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, age ≥18- to ≤55-year-old at the time of signing ICF.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, 12-lead ECG, vital signs measurements, and laboratory tests results, as evaluated by the investigator.
• BMI of 18.0 to 32.0 kg/m2, inclusive, and a body weight of ≥50 kg at Screening.
• \<Patients only\>
• Male or female, age ≥18-year-old at the time of signing ICF.
• A diagnosis of ulcerative colitis (UC) must have been established at least three months prior to screening.
• \<Healthy Volunteers and Patients\>
• Total abstinence, in accordance with the lifestyle of the participant, from at least 30 days prior to the first dose until at least 90 days after the last dose.
• Ability to understand the study procedures described in the ICF. Willingness and ability to comply with the protocol, and provides written informed consent prior to study participation.
• Willingness and ability to swallow study intervention tablets and/or suspension.
• Willing to take off dentures or mouth piercing at the time of dosing.

You may not qualify if:

• Mentally or legally incapacitated.
• History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the investigator or medical monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study, including but not limited to a history of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection or history or clinical evidence of pancreatic injury or pancreatitis, history of cardiac arrhythmia (both atrial and ventricular). History of uncomplicated appendectomy and uncomplicated cholecystectomy are allowed.
• History of any major invasive surgery within 6 months before the first dosing, or minor invasive surgery within 7 days before the first dosing.
• History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.
• History of rare hereditary galactose and/or Lactose intolerance (eg, congenital lactase deficiency \[CLD\] or glucose-galactose malabsorption \[GGM\]).
• History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.
• History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
• Presence of recurring gastrointestinal symptoms (diarrhea, constipation, nausea, heartburn, etc.).
• Presence of acute gastrointestinal symptoms within 7 days before the first dosing.
• Use of medications for the timeframes and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption).
• \<Patients only\>
• Current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischaemic colitis.
• Evidence of fulminant colitis or ASUC at Screening.
• The patient meets the following criteria:
• Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy for UC

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Syneos Health Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Project Leader

  Ono Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)