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NCT04457960
A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis
Phase 1 trial testing JNJ-66525433 in Healthy in 82 participants. Terminated before completion.
13 October 2021
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 1 July 2020 |
| Primary completion | 13 October 2021 |
| Estimated completion | 13 October 2021 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- JNJ-66525433 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
- Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04457960
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04457960 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04457960.
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