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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Amphotericin B; Liposomal amphotericin B

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.