Phase I Study of Kukoamine B Mesilate in Healthy Volunteers

May 2, 2017 updated by: Tianjin Chasesun Pharmaceutical Co., LTD

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events.
Time Frame: 7 days
AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 .
48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Chasesun Pharmaceutical Co., LTD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Southwest Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SHUAI CHEN, TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-KB101
  • ChiCTR-TRC-14005111 (Registry Identifier: Chinese Clinical Trial Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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