Status:
TERMINATED
A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Colitis, Ulcerative
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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 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
- 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
- For Part 3, participants with UC
- 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
- COVID-related
- 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. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations / guidance from authorities / standards of care
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04457960
Start Date
July 1 2020
End Date
October 13 2021
Last Update
February 3 2025
Active Locations (1)
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1
Charite Research Organisation GmbH
Berlin, Germany, 10117