Phase I Study of Kukoamine B Mesilate in Healthy Volunteers

NCT ID: NCT02219971

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-05-06

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Kukoamine B Mesilate

Intervention Type: DRUG

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

Interventions

Kukoamine B Mesilate

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: collaborator

Tianjin Chasesun Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SHUAI CHEN

Role: STUDY_DIRECTOR

TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38291280 (View on PubMed)

Other Identifiers

ChiCTR-TRC-14005111

Identifier Type: REGISTRY

Identifier Source: secondary_id

HR-KB101

Identifier Type: -

Identifier Source: org_study_id