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Phase I Study of Kukoamine B Mesilate in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219971
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Southwest Hospital, China
Information provided by (Responsible Party):
Tianjin Chasesun Pharmaceutical Co., LTD

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Kukoamine B Mesilate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2014
Actual Primary Completion Date : May 6, 2015
Actual Study Completion Date : May 6, 2015

Arm Intervention/treatment
Experimental: 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.
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 0.02mg/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.

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 0.04mg/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.

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 0.08mg/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.

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 + 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.

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 + 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.

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 0.48mg/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.

Drug: Kukoamine B Mesilate
Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.




Primary Outcome Measures :
  1. Incidence of adverse events. [ Time Frame: 7 days ]
    AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.


Secondary Outcome Measures :
  1. Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h) [ Time Frame: 48h ]
    Blood:(Pre Test)0,20min,40min after initiation of drug administration and 0,10min,20min,30min,45min,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h,24h after the end of administration;(Formal Test) 0,20min,40min after initiation of drug administration and 0,30min,1h,2h,3h,4h,6h,8h,12h,16h,24h after the end of administration; Urine:(Pre Test) 0,0-4h,4-8h,8-12h,12-24h,24-48h after initiation of drug administration;(Formal Test) 0,0-5h,5-9h,9-13h,13-25h,25-49h after initiation of drug administration .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • 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, food additives), 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 CRF;
  • The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
  • 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;
  • Lactating women, pregnant women or unable to take effective contraceptive measures;
  • Researchers believe that the other is not suitable to take the test factors participants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219971


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China
Sponsors and Collaborators
Tianjin Chasesun Pharmaceutical Co., LTD
Southwest Hospital, China
Investigators
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Study Director: SHUAI CHEN TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD
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Responsible Party: Tianjin Chasesun Pharmaceutical Co., LTD
ClinicalTrials.gov Identifier: NCT02219971    
Other Study ID Numbers: HR-KB101
ChiCTR-TRC-14005111 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2016
Keywords provided by Tianjin Chasesun Pharmaceutical Co., LTD:
Healthy