NCT02219971 is a Phase 1 clinical trial of Kukoamine B Mesilate in Healthy, sponsored by Tianjin Chasesun Pharmaceutical Co., LTD.

Who is sponsoring NCT02219971?

NCT02219971 is sponsored by Tianjin Chasesun Pharmaceutical Co., LTD.

What drugs are being tested in NCT02219971?

Interventions in NCT02219971: Kukoamine B Mesilate.

Is NCT02219971 still recruiting?

NCT02219971 is currently completed. Last updated 2 May 2017.

Last reviewed 2017-05-02 · How we verify

NCT02219971

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance and Pharmacokinetics of a Single Intravenous Injection Kukoamine B Mesilate in Healthy Volunteers

Completed Phase 1 Last updated 2 May 2017

What this trial tests

Phase 1 trial testing Kukoamine B Mesilate in Healthy in 52 participants. Completed in 6 May 2015.

Timeline

1 August 2014

Primary endpoint
6 May 2015

6 May 2015

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	52
Start date	1 August 2014
Primary completion	6 May 2015
Estimated completion	6 May 2015
Sites	1 location across China

Drugs / interventions tested

Kukoamine B Mesilate — 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: 7 days
AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.

Sponsor's own description

The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer

Publications & conference data

2 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
First-in-Human Safety, Tolerability, and Pharmacokinetics of Single-Dose Kukoamine B Mesylate in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase I Study.
Liu H, Zhao Q, Yuan Y, Wang Z, et al · · 2024 · cited 1× · PMID 38291280 · DOI 10.1007/s40121-024-00921-6

Verify or expand the search:

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02219971 (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/NCT02219971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing