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
Ono Pharmaceutical Co., Ltd.
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
●Inclusion Criteria: \<Healthy Volunteers only\> * 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 mont…
Interventions
- DrugONO-6414
Administered orally
- DrugPlacebo
Administered orally
Location
- Syneos Health MiamiMiami, Florida