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NCT03103412
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Phase 1 trial testing TD-3504 in Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects in 32 participants. Completed in 8 November 2017.
8 November 2017
Quick facts
| Lead sponsor | Theravance Biopharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 4 May 2017 |
| Primary completion | 8 November 2017 |
| Estimated completion | 8 November 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TD-3504 — full drug profile →
- 15N2-tofacitinib — full drug profile →
- Placebo
Conditions studied
- Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects — all drugs for Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects →
Sponsor
Theravance Biopharma — full company profile →
Who can join
Adults 18 to 55, any sex, with Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463
Verify or expand the search:
- PubMed search for NCT03103412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03103412 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Theravance Biopharma
- Last refreshed: 14 January 2021
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/NCT03103412.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing