Clinical trial NCT02219971: Phase I Study of Kukoamine B Mesilate in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Tianjin Chasesun Pharmaceutical Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Southwest Hospital, China
First posted: 2014-08-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events.
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)
timeFrame: 48h
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD
name: SHUAI CHEN
role: STUDY_DIRECTOR
References: