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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-09-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Invasive Fungal Disease

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABCD

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

Group Type EXPERIMENTAL

ABCD

Intervention Type DRUG

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

Interventions

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ABCD

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes