NCT02219971

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2015

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

August 16, 2014

Last Update Submit

May 2, 2017

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events.

    AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.

    7 days

Secondary Outcomes (1)

  • Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)

    48h

Study Arms (7)

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.

Drug: Kukoamine B Mesilate

Kukoamine B Mesilate 0.24mg/kg + Placebo

EXPERIMENTAL

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.

Drug: Kukoamine B Mesilate

Kukoamine B Mesilate 0.48mg/kg + Placebo

EXPERIMENTAL

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.

Drug: Kukoamine B Mesilate

Interventions

Kukoamine B MesilateDRUG

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

Kukoamine B Mesilate 0.005mg/kgKukoamine B Mesilate 0.02mg/kg + PlaceboKukoamine B Mesilate 0.04mg/kg +PlaceboKukoamine B Mesilate 0.08mg/kg + PlaceboKukoamine B Mesilate 0.12mg/kg + PlaceboKukoamine B Mesilate 0.24mg/kg + PlaceboKukoamine B Mesilate 0.48mg/kg + Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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), 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\~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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 38291280DERIVED

Study Officials

  • SHUAI CHEN

    TIAN JIN CHASE SUN 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

August 16, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

May 6, 2015

Study Completion

May 6, 2015

Last Updated

May 3, 2017

Record last verified: 2016-05

Locations

CN(1)