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NCT05091723
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Phase 1 trial testing Nezulcitinib (TD-0903) Dose A in Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) in 14 participants. Completed in 24 November 2021.
24 November 2021
Quick facts
| Lead sponsor | Theravance Biopharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 13 October 2021 |
| Primary completion | 24 November 2021 |
| Estimated completion | 24 November 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nezulcitinib (TD-0903) Dose A — full drug profile →
- Nezulcitinib (TD-0903) Dose B — full drug profile →
Conditions studied
- Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) — all drugs for Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) →
Sponsor
Theravance Biopharma — full company profile →
Who can join
Adults 18 to 65, any sex, with Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154 -
Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review.
Jain NK, Tailang M, Jain HK, Chandrasekaran B, et al · · 2023 · cited 24× · PMID 37021053 · DOI 10.3389/fphar.2023.1135145 -
Different drug approaches to COVID-19 treatment worldwide: an update of new drugs and drugs repositioning to fight against the novel coronavirus.
Oliver JC, Silva EN, Soares LM, Scodeler GC, et al · · 2022 · cited 10× · PMID 36578829 · DOI 10.1177/25151355221144845
Verify or expand the search:
- PubMed search for NCT05091723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Theravance Biopharma trials
Trials by the same sponsor.
- NCT05165485 — Phase 4 COPD and Suboptimal Inspiratory Flow Rate · Phase 4 · completed
- NCT04681079 — Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19 · completed
- NCT04688632 — Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects · Phase 1 · completed
- NCT04587713 — Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects · Phase 1 · completed
- NCT04589260 — TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis · Phase 1 · terminated
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 NCT05091723 (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: 10 December 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/NCT05091723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing