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

Invasive Fungal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577509
• Other study ID #: LXMSB201701/PRO
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2018
• Est. completion date: September 14, 2018

Study information

• Verified date: May 2018
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Disease
• Invasive Fungal Infections
• Mycoses

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of single infusion of ABCD	Peak Plasma Concentration,.	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
Primary	Pharmacokinetics of single infusion of ABCD	Area under the plasma concentration versus time curve	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