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Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Primary Purpose

Invasive Fungal Disease

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

ABCD

About this trial

This is an interventional treatment trial for Invasive Fungal Disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/[height(m)]2.
Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

History of allergy or hypersensitivity.
Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc.
A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
Lost blood or donated more than 400 mL of blood within 3 months prior to the screening.
Participation in a clinical drug study 30 days prior to present study.
Use of any other drugs within 2 weeks prior to the screening.
Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
The partner of the subject is unwilling to take effective contraceptive measures.
Other unfavorable factors diagnosed by investigators.

Sites / Locations

Huashan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABCD

Arm Description

Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg

Outcomes

Primary Outcome Measures

Pharmacokinetics of single infusion of ABCD

Peak Plasma Concentration,.

Pharmacokinetics of single infusion of ABCD

Area under the plasma concentration versus time curve

Secondary Outcome Measures

Full Information

NCT ID

NCT03577509

First Posted

May 28, 2018

Last Updated

October 7, 2018

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03577509

Brief Title

Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Official Title

Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

July 2, 2018 (Actual)

Primary Completion Date

September 14, 2018 (Actual)

Study Completion Date

September 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.

Detailed Description

Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Fungal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABCD

Arm Type

Experimental

Arm Description

Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg

Intervention Type

Drug

Intervention Name(s)

ABCD

Intervention Description

Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.

Primary Outcome Measure Information:

Title

Pharmacokinetics of single infusion of ABCD

Description

Peak Plasma Concentration,.

Time Frame

before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion

Title

Pharmacokinetics of single infusion of ABCD

Description

Area under the plasma concentration versus time curve

Time Frame

before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/[height(m)]2. Subjects are fully informed and voluntarily consent to participate in this study. Exclusion Criteria: History of allergy or hypersensitivity. Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc. A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test. Lost blood or donated more than 400 mL of blood within 3 months prior to the screening. Participation in a clinical drug study 30 days prior to present study. Use of any other drugs within 2 weeks prior to the screening. Subjects planning to give birth or donate sperm during the study or within 3 months after the study. The partner of the subject is unwilling to take effective contraceptive measures. Other unfavorable factors diagnosed by investigators.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Zhang, Ph.D

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huashan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34686365

Citation

Huang ZW, Yu JC, Wang JJ, Chen YC, Wu JF, Chen YJ, Cao GY, Yang HJ, He JJ, Dai JY, Zhang JY, Zhang W, Yuan J, Li CL, Xu FY, Wang K, Wu XJ, Zhang J. Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans. Clin Ther. 2021 Nov;43(11):1921-1933.e7. doi: 10.1016/j.clinthera.2021.09.012. Epub 2021 Oct 20.

Results Reference

derived

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Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

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