NCT04457960

A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).

Conditions

• Healthy
• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	JNJ-66525433	Participants will receive JNJ-66525433 oral capsules.
DRUG	Placebo	Participants will receive matching placebo oral capsules.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2020-07-07
• Last updated: 2025-02-03

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study