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NCT05576454
Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects
Phase 1 trial testing Mepolizumab Injection (BAT2606 Injection) in Severe Asthma in 207 participants. Completed in 19 June 2023.
26 May 2023
Quick facts
| Lead sponsor | Bio-Thera Solutions |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 207 |
| Start date | 20 September 2022 |
| Primary completion | 26 May 2023 |
| Estimated completion | 19 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mepolizumab Injection (BAT2606 Injection) — full drug profile →
- Mepolizumab Injection (EU-licensed Nucala) — full drug profile →
- Mepolizumab Injection (US-licensed Nucala) — full drug profile →
Conditions studied
- Severe Asthma — all drugs for Severe Asthma →
Sponsor
Bio-Thera Solutions — full company profile →
Who can join
Adults 18 to 55, male only, with Severe Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male 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 NCT05576454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Asthma
Currently open trials in the same condition.
- NCT07363642 — Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab · Phase 3 · recruiting
- NCT07328035 — Remission in Adults With Severe Asthma in Thailand · recruiting
- NCT07530770 — Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis · recruiting
- NCT06903780 — Experience of Biologic Treatments for Severe Asthma: a Survey · recruiting
- NCT06681545 — Exploring the Lived Experience of Young Adults With Severe Asthma · recruiting
Other Bio-Thera Solutions trials
Trials by the same sponsor.
- NCT07499700 — A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis · Phase 2, PHASE3 · recruiting
- NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting
- NCT06545617 — A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer · Phase 1, PHASE2 · withdrawn
- NCT07515079 — Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema · Phase 3 · recruiting
- NCT06280196 — A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants Wit · Phase 3 · 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 NCT05576454 (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 Bio-Thera Solutions
- Last refreshed: 28 August 2023
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/NCT05576454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing