NCT03577509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

October 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 28, 2018

Last Update Submit

October 7, 2018

Conditions

Invasive Fungal Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

ABCD

EXPERIMENTAL

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

Drug: ABCD

Interventions

ABCDDRUG

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

ABCD

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

  • Huang ZW, Yu JC, Wang JJ, Chen YC, Wu JF, Chen YJ, Cao GY, Yang HJ, He JJ, Dai JY, Zhang JY, Zhang W, Yuan J, Li CL, Xu FY, Wang K, Wu XJ, Zhang J. Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans. Clin Ther. 2021 Nov;43(11):1921-1933.e7. doi: 10.1016/j.clinthera.2021.09.012. Epub 2021 Oct 20.

    PMID: 34686365DERIVED

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Jing Zhang, Ph.D

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

July 5, 2018

Study Start

July 2, 2018

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

October 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)