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NCT04044339
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
Phase 1 trial testing TD-5202 in Healthy in 56 participants. Completed in 27 November 2019.
27 November 2019
Quick facts
| Lead sponsor | Theravance Biopharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 8 August 2019 |
| Primary completion | 27 November 2019 |
| Estimated completion | 27 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TD-5202 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Theravance Biopharma — full company profile →
Who can join
Adults 19 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04044339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Theravance Biopharma trials
Trials by the same sponsor.
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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 NCT04044339 (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 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/NCT04044339.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing