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

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

1

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

JNJ-66525433

Placebo

Clinical Study ID

NCT04457960
CR108764
66525433IBD1001
2018-003743-29
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

For Part 1 and Part 2, healthy volunteers

  • Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height), inclusive, and a body weight of no less than 50 kilogram (kg)and maximum weight of 100 kg

  • Have normal bowel movements, ranging from 1 to 3 times daily to every other day andhave normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5at admission

For Part 3, participants with ulcerative colitis (UC)

  • Have a clinical diagnosis of UC at least 3 months before screening

  • Have moderately to severely active UC, defined as a Week 0 mayo score of 6 to 12,inclusive, based on central read of the video endoscopy performed during thescreening

  • Have a greater than or equal to (>=) 2 endoscopy subscore of the Week 0 mayo scorebased on central read of the video endoscopy performed during the screening

Exclusion

Exclusion Criteria:

For Part 1 and Part 2, healthy volunteers

  • History of liver or renal insufficiency, significant cardiac, vascular, pulmonary,gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, ormetabolic disturbances

  • Known allergies, hypersensitivity, or intolerance to antisense oligonucleotides,JNJ-66525433 or its excipients

For Part 3, participants with UC

  • Has UC limited to the rectum only or to <20 centimeter (cm) of the colon evaluatedby endoscopy at screening

  • Presence of a stoma

  • Presence or history of a fistula at any time

COVID-related

  • If a participant is excluded due to recent Coronavirus disease (COVID-19) relatedfeatures, the reason for screen failure should be documented in the case report formunder the exclusion criterion of having a condition for which participation wouldnot be in the participant's interest or could confound study assessments

  • The field of COVID-related testing (for presence of, and immunity to, the severeacute respiratory syndrome coronavirus 2 [SARS-CoV-2] virus) is rapidly evolving.Additional testing may be performed as part of screening and/or during the study ifdeemed necessary by the investigator and in accordance with current regulations /guidance from authorities / standards of care

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: JNJ-66525433
Phase: 1
Study Start date:
July 01, 2020
Estimated Completion Date:
October 13, 2021

Connect with a study center

  • Arensia Exploratory Medicine

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Charite Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Arensia Exploratory Medicine - Clinical Republican Hospital

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

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