NCT03237728

Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

Randomized, Double-blind Placebo-controlled Clinical Study to Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Tianjin Chasesun Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Detailed description

To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	0.06mg/kg,KB	0.06mg/kg,Q8h,Day1-Day7
DRUG	0.12mg/kg,KB	0.12mg/kg,Q8h,Day1-Day7
DRUG	0.24mg/,KB	0.24mg/kg,Q8h,Day1-Day7
DRUG	Placebos	Placebos,Q8h,Day1-Day7

Timeline

• Start date: 2017-07-28
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2017-08-02
• Last updated: 2020-01-22

Locations

1 site across 1 country: China