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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Invasive Fungal Disease

Treatments: Drug: ABCD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03577509

LXMSB201701/PRO

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

30 participants in 1 patient group

ABCD

Experimental group

Description:

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

Treatment:

Drug: ABCD