Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 60 Years|
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 and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission.
- - 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 the screening.
- - Have a greater than or equal to (>=) 2 endoscopy subscore of the Week 0 mayo score based on central read of the video endoscopy performed during the screening.
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, or metabolic disturbances.
- - Known allergies, hypersensitivity, or intolerance to antisense oligonucleotides, JNJ-66525433 or its excipients.
- - Has UC limited to the rectum only or to <20 centimeter (cm) of the colon evaluated by endoscopy at screening.
- - Presence of a stoma.
- - Presence or history of a fistula at any time.
- - If a participant is excluded due to recent Coronavirus disease (COVID-19) related features, the reason for screen failure should be documented in the case report form under the exclusion criterion of having a condition for which participation would not be in the participant's interest or could confound study assessments.
- - The field of COVID-related testing (for presence of, and immunity to, the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] virus) is rapidly evolving.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Janssen Research & Development, LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Janssen Research & Development, LLC Clinical Trial|
|Principal Investigator Affiliation||Janssen Research & Development, LLC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Georgia, Germany, Moldova, Republic of|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Healthy, Colitis, Ulcerative|
|Study Website:||View Trial Website|
Participants will receive JNJ-66525433 in increasing dose level 1 to dose level 4 in Parts 1, 2, and dose level 3 in part 3.
Placebo Comparator: Placebo
Participants will receive matching placebo in Parts 1, 2 and 3.
Drug: - JNJ-66525433
Participants will receive JNJ-66525433 oral capsules.
Drug: - Placebo
Participants will receive matching placebo oral capsules.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.