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NCT02690961
Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance，Pharmacokinetics of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers
Phase 1 trial testing Kukoamine B Mesilate in Healthy in 24 participants. Completed in 14 June 2016.
14 June 2016
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 | 24 |
| Start date | 1 March 2016 |
| Primary completion | 14 June 2016 |
| Estimated completion | 14 June 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Kukoamine B Mesilate — full drug profile →
- placebo multiple doses — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Tianjin Chasesun Pharmaceutical Co., LTD — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of adverse events.
Time frame: 14 days
adverse event, physical examination, monitoring of vital signs, Laboratory examination, electrocardiogram(ECG).
Sponsor's own description
The purpose of this study is to assess safety, tolerance and pharmacokinetics of Multiple-dose Kukoamine B Mesilate in healthy volunteers
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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
Verify or expand the search:
- PubMed search for NCT02690961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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
- NCT03237728 — Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients · 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 NCT02690961 (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: 2 May 2017
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/NCT02690961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing