Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
JNJ-66525433
Placebo
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Arensia Exploratory Medicine
Tbilisi, 0112
GeorgiaSite Not Available
Charite Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
Charité Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
Arensia Exploratory Medicine - Clinical Republican Hospital
Chisinau, MD-2025
Moldova, Republic ofSite Not Available

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