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NCT07035652
The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations
Phase 1 trial testing XH-S004 20 mg, 40 mg or 60 mg in Chronic Obstructive Pulmonary Disease (COPD) in 81 participants. Not yet recruiting.
13 November 2026
Quick facts
| Lead sponsor | S-INFINITY Pharmaceuticals Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 15 July 2025 |
| Primary completion | 13 November 2026 |
| Estimated completion | 13 November 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- XH-S004 20 mg, 40 mg or 60 mg
- Placebo
Conditions studied
- Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →
Sponsor
S-INFINITY Pharmaceuticals Co., Ltd — full company profile →
Who can join
Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neutrophils as critical orchestrators of chronic inflammation.
Torfs K, Vermeersch G, Gouwy M, Devos T, et al · · 2026 · cited 2× · PMID 41530536 · DOI 10.1038/s41423-025-01380-w -
Tackling Neutrophilic Inflammation in Bronchiectasis: From Macrolides to Cathepsin C Inhibitors.
Gramegna A, Premuda C, Putti G, Piedepalumbo FV, et al · · 2026 · PMID 41993889 · DOI 10.2147/jir.s558745
Verify or expand the search:
- PubMed search for NCT07035652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Obstructive Pulmonary Disease (COPD)
Currently open trials in the same condition.
- NCT07451977 — Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia · NA · recruiting
- NCT07355868 — Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy · EARLY_PHASE1 · recruiting
- NCT06892210 — Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) · Phase 4 · recruiting
- NCT07477600 — cfMSC Stem Cell Therapy Targeting COPD · Phase 1, PHASE2 · recruiting
- NCT07519603 — Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program · NA · recruiting
Other S-INFINITY Pharmaceuticals Co., Ltd trials
Trials by the same sponsor.
- NCT06981091 — A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Effica · Phase 2 · not yet recruiting
- NCT06978699 — A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobin · Phase 2 · recruiting
- NCT06236841 — A Phase I Study of XH-S004 in Healthy Volunteers · Phase 1 · unknown
- NCT05946876 — A Phase 1 Study of XH-S003 in Healthy Volunteers · Phase 1 · completed
- NCT06272747 — Study of XH-S003 in Healthy Volunteers · Phase 1 · completed
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 NCT07035652 (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 S-INFINITY Pharmaceuticals Co., Ltd
- Last refreshed: 25 June 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/NCT07035652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing