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

Phase 1

Completed

• Conditions: Invasive Fungal Disease
• Interventions: Drug: ABCD

• Registration Number: NCT03577509
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study Start: 2018-07-02
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-05
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-14
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ABCD	ABCD	Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of single infusion of ABCD	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	Area under the plasma concentration versus time curve

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China