Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

NCT02690961 | Completed Phase 1

• 2 other identifiers: HR-KB103ChiCTR-TRC-14005111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events.

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

  14 days

Secondary Outcomes (1)

• Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax])

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

Other Outcomes (1)

• Pharmacokinetic parameters(Area Under Curve [AUC])

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

Study Arms (6)

Kukoamine B Mesilate 0.06mg/kg

EXPERIMENTAL

Dose Escalation: Kukoamine B Mesilate 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: Kukoamine B Mesilate

Kukoamine B Mesilate 0.12mg/kg

EXPERIMENTAL

Dose Escalation: Kukoamine B Mesilate 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: Kukoamine B Mesilate

Kukoamine B Mesilate 0.24mg/kg

EXPERIMENTAL

Dose Escalation: Kukoamine B Mesilate 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: Kukoamine B Mesilate

Placebo 0.06mg/kg

EXPERIMENTAL

Dose Escalation: placebo 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: placebo multiple doses

Placebo 0.12mg/kg

EXPERIMENTAL

Dose Escalation: placebo 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: placebo multiple doses

Placebo 0.24mg/kg

EXPERIMENTAL

Dose Escalation: placebo 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.

Drug: placebo multiple doses

Interventions

Kukoamine B Mesilate DRUG

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

Kukoamine B Mesilate 0.06mg/kg; Kukoamine B Mesilate 0.12mg/kg; Kukoamine B Mesilate 0.24mg/kg

placebo multiple doses DRUG

Placebo 0.06mg/kg; Placebo 0.12mg/kg; Placebo 0.24mg/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: male or female, each sex ratio does not exceed 2/3;
• 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), bodyweight（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.

You may not qualify if:

• 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 90-140 millimeters of mercury(mmHg), beyond the scope of 50-90 millimeters of mercury(mmHg), 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;
• 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;
• 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, 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）;
• 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 participants not suitable to take the test for other factors .

Sponsors & Collaborators

• Tianjin Chasesun Pharmaceutical Co., LTD: lead
• Southwest Hospital, China: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Zhao Q, Liu H, Wang Z, Wang T, Cui C, Wang H, Li L, Zhong W, Jiang J, Dong K, Chen S, Jin C, Hu P. Safety, Tolerability, and Pharmacokinetics of Kukoamine B in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Study. Adv Ther. 2023 Jul;40(7):3186-3198. doi: 10.1007/s12325-023-02521-1. Epub 2023 May 26.

  PMID: 37233875 DERIVED

Study Officials

• Shuai Chen

  Tianjin Chasesun Pharmaceutical Co., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: May 3, 2017

Record last verified: 2016-02

Locations

CN (1)