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
Overview
- Phase
- Phase 1
- Intervention
- Kukoamine B Mesilate
- Conditions
- Healthy
- Sponsor
- Tianjin Chasesun Pharmaceutical Co., LTD
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gender: male or female, each sex ratio does not exceed 2/3;
- •18-45 years (including upper and lower limit), the general situation is good;
- •Body mass index (BMI) in 19-28 (including upper and lower limit of the range), BW ≥ 50kg (female) and 60kg (male);
- •Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
- •Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.
Exclusion Criteria
- •Primary disease in important organs;
- •Mental or physical disability;
- •Familial hereditary disease;
- •Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90\~140mmHg, beyond the scope of 50\~90mmHg, Or pulse (HR) beyond 50bpm\~100bpm
- •Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
- •History of immunodeficiency diseases, including HIV antibody positive;
- •Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
- •Alcohol and drug abusers;
- •Smoking and drinking are (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;
- •Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
Arms & Interventions
Kukoamine B Mesilate 0.005mg/kg
Pre-test,open study: Kukoamine B Mesilate 0.005mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.02mg/kg + Placebo
Dose Escalation: Kukoamine B Mesilate 0.02mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.04mg/kg +Placebo
Dose Escalation: Kukoamine B Mesilate 0.04mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.08mg/kg + Placebo
Dose Escalation: Kukoamine B Mesilate 0.08mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.12mg/kg + Placebo
Dose Escalation: Kukoamine B Mesilate 0.12mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.24mg/kg + Placebo
Dose Escalation: Kukoamine B Mesilate 0.24mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Kukoamine B Mesilate 0.48mg/kg + Placebo
Dose Escalation: Kukoamine B Mesilate 0.48mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
Intervention: Kukoamine B Mesilate
Outcomes
Primary Outcomes
Incidence of adverse events.
Time Frame: 7 days
AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.
Secondary Outcomes
- Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)(48h)