Phase I Study of Kukoamine B Mesilate in Healthy Volunteers | NCT02219971

NCT02219971

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
ChiCTR-TRC-14005111	Registry Identifier	Chinese Clinical Trial Registry

Status Module

Name	Class
Southwest Hospital, China	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kukoamine B Mesilate 0.005mg/kg	Experimental	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 0.02mg/kg + Placebo	Experimental	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 0.04mg/kg +Placebo	Experimental	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 0.08mg/kg + Placebo	Experimental	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 0.12mg/kg + Placebo	Experimental	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kukoamine B Mesilate	Drug	Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.	Kukoamine B Mesilate 0.005mg/kg Kukoamine B Mesilate 0.02mg/kg + Placebo

Outcomes Module

Measure	Description	Time Frame
Incidence of adverse events.	AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)	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 .

Eligibility Module

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.

Name	Affiliation	Role
SHUAI CHEN	TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38291280	Derived	Liu H, Zhao Q, Yuan Y, Wang Z, Wang T, Tian W, Zhong W, Jiang J, Chen S, Kong K, Jin C, Hu P. First-in-Human Safety, Tolerability, and Pharmacokinetics of Single-Dose Kukoamine B Mesylate in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase I Study. Infect Dis Ther. 2024 Feb;13(2):361-371. doi: 10.1007/s40121-024-00921-6. Epub 2024 Jan 30.