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NCT03237728
Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients
Phase 1 trial testing 0.06mg/kg,KB in Sepsis in 44 participants. Completed in 25 September 2019.
25 September 2019
Quick facts
| Lead sponsor | Tianjin Chasesun Pharmaceutical Co., LTD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 28 July 2017 |
| Primary completion | 25 September 2019 |
| Estimated completion | 25 September 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- 0.06mg/kg,KB — full drug profile →
- 0.12mg/kg,KB — full drug profile →
- 0.24mg/,KB — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Tianjin Chasesun Pharmaceutical Co., LTD — full company profile →
Who can join
Adults 18 to 70, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exposure-Response Modeling to Support Dosing Selection for Phase IIb Development of Kukoamine B in Sepsis Patients.
Wang H, Hu X, Wang T, Cui C, et al · · 2021 · cited 5× · PMID 33953679 · DOI 10.3389/fphar.2021.645130 -
Safety, Tolerability, and Pharmacokinetics of Kukoamine B in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Study.
Zhao Q, Liu H, Wang Z, Wang T, et al · · 2023 · cited 3× · PMID 37233875 · DOI 10.1007/s12325-023-02521-1 -
Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial.
Hu XY, Zhang W, Wang D, Sun Y, et al · · 2023 · cited 3× · PMID 37116228 · DOI 10.1016/j.jcrc.2023.154294
Verify or expand the search:
- PubMed search for NCT03237728
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other Tianjin Chasesun Pharmaceutical Co., LTD trials
Trials by the same sponsor.
- NCT04803955 — Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients · Phase 2 · recruiting
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 NCT03237728 (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 Tianjin Chasesun Pharmaceutical Co., LTD
- Last refreshed: 22 January 2020
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/NCT03237728.
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