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

NCT04457960 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-02-03

No results posted yet for this study

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

DRUG

JNJ-66525433

Participants will receive JNJ-66525433 oral capsules.

DRUG

Placebo

Participants will receive matching placebo oral capsules.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-10-13
Completion
2021-10-13
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457960 on ClinicalTrials.gov