Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance，Pharmacokinetics of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

The purpose of this study is to assess safety, tolerance and pharmacokinetics of Multiple-dose Kukoamine B Mesilate in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Kukoamine B Mesilate; Drug: placebo multiple doses

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Gender: male or female, each sex ratio does not exceed 2/3;
2. 18-45 years (including upper and lower limit), the general situation is good;
3. Body mass index (BMI) in 19-28 (including upper and lower limit of the range), bodyweight（BW）≥ 50kg (female) and 60kg (male);
4. 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;
5. 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:

1. Primary disease in important organs;
2. Mental or physical disability;
3. Familial hereditary disease;
4. Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90-140 millimeters of mercury(mmHg), beyond the scope of 50-90 millimeters of mercury(mmHg), Or pulse (HR) beyond 50bpm-100bpm;
5. Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
6. History of immunodeficiency diseases, including HIV antibody positive;
7. Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
8. Alcohol and drug abusers;
9. Who is addicted to alcohol and tobacco (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;
10. Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
11. Before entering the group 4 weeks using any prescription drugs before entering the group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics, etc.), or into the group within 2 weeks before taking effect of drug metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in case report form（CRF）;
12. The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
13. There are drugs, the clinical significance of the history of food allergy and atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs or similar drug allergy test;
14. Lactating women, pregnant women or unable to take effective contraceptive measures;
15. Researchers believe that participants not suitable to take the test for other factors .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kukoamine B Mesilate 0.06mg/kg; Dose Escalation: Kukoamine B Mesilate 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: Kukoamine B Mesilate; Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Experimental: Kukoamine B Mesilate 0.12mg/kg; Dose Escalation: Kukoamine B Mesilate 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: Kukoamine B Mesilate; Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Experimental: Kukoamine B Mesilate 0.24mg/kg; Dose Escalation: Kukoamine B Mesilate 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: Kukoamine B Mesilate; Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Experimental: Placebo 0.06mg/kg; Dose Escalation: placebo 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: placebo multiple doses
Experimental: Placebo 0.12mg/kg; Dose Escalation: placebo 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: placebo multiple doses
Experimental: Placebo 0.24mg/kg; Dose Escalation: placebo 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Drug: placebo multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events.	adverse event, physical examination, monitoring of vital signs, Laboratory examination, electrocardiogram(ECG).	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax])	before the first injecting(omin); after starting the first injecting 30min;ending the first injecting instantly,1h,3h,6h,8h,12h,16h,23h;before the three injections from bottom,after starting the last injecting 30min,ending the last injecting instantly,1h,3h,6h,8h,12h,16h,23h.	the first day,the sixth day(before the three injections from bottom),the seventh day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters(Area Under Curve [AUC])	before the first injecting(omin); after starting the first injecting 30min;ending the first injecting instantly,1h,3h,6h,8h,12h,16h,23h;before the three injections from bottom,after starting the last injecting 30min,ending the last injecting instantly,1h,3h,6h,8h,12h,16h,23h.	the first day,the sixth day(before the three injections from bottom),the seventh day

Collaborators and Investigators

• Sponsor: Tianjin Chasesun Pharmaceutical Co., LTD
• Collaborators: Southwest Hospital, China
• Investigators: Study Director: Shuai Chen, Tianjin Chasesun Pharmaceutical Co., LTD

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 14, 2016
• Study Completion (Actual): June 14, 2016

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: HR-KB103; ChiCTR-TRC-14005111 (Registry Identifier: Chinese Clinical Trial Registry)