Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

Randomized, Double-blind Placebo-controlled Clinical Study to Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: 0.06mg/kg,KB; Drug: Placebos; Drug: 0.12mg/kg,KB; Drug: 0.24mg/,KB

Detailed Description

To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B Mesilate in Sepsis Patients

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The age of ≥ 18 years of age and ≤ 70 years of age, gender is not limited;
2. Confirmed or suspected bacterial infection (refer to Appendix 5);
3. Infection-related organ failure does not exceed 24 hours; organ failure is defined as circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory, kidney, liver, coagulation and central nervous system;
4. The time interval between the selection of the test drug and the test drug is not more than 8 hours;
5. Infertility test for women of childbearing age;
6. Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
7. Patients or legal representatives signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, or unable to take effective measures of contraception;
2. Patients are expected to live less than 28 days due to basic diseases, such as poor control of malignant tumor, cardiac arrest in 30 days, and end-stage lung disease.
3. The patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the APACHE II score) : a) heart: New York heart association cardiac function IV; B) breathing: chronic obstructive, obstructive, or vascular lung disease can lead to severe restrictions on activities, i.e. the inability to go upstairs or to do housework; Or clear chronic hypoxia, CO2 retention, secondary real erythrocyte, severe pulmonary hypertension (> 40 mmHg) or respiratory muscle dependence; C) kidneys: receiving long-term dialysis; D) liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; The upper digestive tract hemorrhage caused by portal hypertension; Or previous liver failure/hepatic encephalopathy/hepatic coma; E) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiation therapy, or for a long time the recent use of high doses of hormones), or sickness impact resistance to infection, such as leukemia, lymphoma and AIDS);
4. Solid organ or bone marrow transplantation;
5. Plant survival status;
6. The following conditions occurred within 4 weeks prior to infection: a) acute pulmonary embolism; B) transfusion response; C) acute coronary syndrome;
7. Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity and active tuberculosis;
8. Patients with sinus bradycardia (less than 60 per minute);
9. Severe anemia (hemoglobin < 7.0 g/dL);
10. Uncontrolled bleeding in the past 24 hours;
11. Large area burns or chemical burns (III degree burns area > 30% BSA);
12. The average arterial pressure was < 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy.
13. Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC < 500 / mm3), or severe thrombocytopenia (< 20,000 / mm3);
14. Allergic to the active ingredient or its auxiliary materials;
15. The medication patients are using may severely affect the metabolism of the drug;
16. Patients and (or) legal representatives have signed an unresuscitation (DNR), or decided to withdraw life support (withdraw) or restrict life support for the intensity (of the patient) and sign the informed consent form;
17. Participated in clinical intervention test in 3 months;
18. The subject is a researcher or his immediate family member, or may have improper informed consent;
19. The attending physician considers it inappropriate for the patient to participate in this test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.06mg/kg,KB and Placebo; Group A:0.06mg/kg,Q8h,Day1-Day7	Drug: 0.06mg/kg,KB; 0.06mg/kg,Q8h,Day1-Day7; Drug: Placebos; Placebos,Q8h,Day1-Day7
EXPERIMENTAL: 0.12mg/kg,KB; Group B:0.12mg/kg,Q8h,Day1-Day7	Drug: 0.12mg/kg,KB; 0.12mg/kg,Q8h,Day1-Day7
EXPERIMENTAL: 0.24mg/kg,KB; Group C:0.24mg/kg,Q8h,Day1-Day7	Drug: 0.24mg/,KB; 0.24mg/kg,Q8h,Day1-Day7
EXPERIMENTAL: Placebos; Group D:Placebos,Q8h,Day1-Day7	Drug: Placebos; Placebos,Q8h,Day1-Day7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	AE, physical examination, monitoring of vital signs, Laboratory examination etc.	Day-1 to Day8

Collaborators and Investigators

• Sponsor: Tianjin Chasesun Pharmaceutical Co., LTD
• Collaborators: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2017
• Primary Completion (ACTUAL): September 25, 2019
• Study Completion (ACTUAL): September 25, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (ACTUAL): August 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: HR-KB104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No