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CompletedNCT02690961Updated May 3, 2017

Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

A Phase 1 interventional study of Kukoamine B Mesilate and placebo multiple doses in Healthy, sponsored by Tianjin Chasesun Pharmaceutical Co., LTD. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by Tianjin Chasesun Pharmaceutical Co., LTD · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Healthy
03

In context

Lead sponsor

Tianjin Chasesun Pharmaceutical Co., LTD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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 .
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugKukoamine B Mesilate

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

  • Drugplacebo multiple doses
06

What researchers measure

Primary outcomes

  1. Incidence of adverse events.

    adverse event, physical examination, monitoring of vital signs, Laboratory examination, electrocardiogram(ECG).

    Time frame: 14 days

Secondary outcomes

  1. 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.

    Time frame: the first day,the sixth day(before the three injections from bottom),the seventh day

Other outcomes

  1. 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.

    Time frame: the first day,the sixth day(before the three injections from bottom),the seventh day

07

Study locations

1 site
  • Peking Union Medical College Hospital
    BeiJing, Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02690961
Lead sponsor
Tianjin Chasesun Pharmaceutical Co., LTD
Collaborators
Southwest Hospital, China
Responsible party
Sponsor
First posted
Feb 24, 2016
Start date
Mar 2016
Primary completion
Jun 14, 2016
Completion
Jun 14, 2016
Last update
May 3, 2017

Study contacts

Shuai Chen
study director · Tianjin Chasesun Pharmaceutical Co., LTD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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