NCT04993222

Brief Summary

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2020

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

Study Start

First participant enrolled

June 4, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 7, 2021

Last Update Submit

July 28, 2021

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

  • Bioequivalence based on Cmax

    90% CI of Cmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • Bioequivalence based on AUC0-t

    90% CI of AUC0-t of liposome-encapsulated andnon-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • Bioequivalence based on AUCinf

    90% CI of AUC0-∞ of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

Secondary Outcomes (5)

  • Tmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • t1/2 of liposome-encapsulated and non-liposome-encapsulated Amphotericin B

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • λz of liposome-encapsulated and non-liposome-encapsulated Amphotericin B

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • Residual area of liposome-encapsulated and non-liposome-encapsulated Amphotericin B

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

  • Number of treatment-emergent adverse events for the test and the reference products

    predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion

Study Arms (2)

Sequence TR

EXPERIMENTAL

6 healthy subjects assigned to the sequence TR were administrated intravenously for 120 mins with the test product of amphotericin B liposome for injection in period 1 and the reference product of AmBisome® in period 2.

Drug: Amphotericin B liposome for injectionDrug: AmBisome®

Sequence RT

EXPERIMENTAL

6 healthy subjects assigned to the sequence RT were administrated intravenously for 120 mins with the reference product of AmBisome® in period 1 and the test product of amphotericin B liposome for injection in period 2.

Drug: Amphotericin B liposome for injectionDrug: AmBisome®

Interventions

Amphotericin B liposome for injectionDRUG

IV infusion

Also known as: the test product
Sequence RTSequence TR
AmBisome®DRUG

IV infusion

Also known as: the reference product
Sequence RTSequence TR

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects fully understand and voluntarily participate in this study and sign informed consent.
  • Healthy female and male volunteers aged 18-55 years.
  • Body weight ≥ 50 kg for male and ≥ 45 kg for female with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (inclusive).
  • Subjects must be in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
  • Able to communicate well with the investigator and comply with the requirements of the study.

You may not qualify if:

  • History of allergic reactions to amphotericin B or its analogs. History of allergy to two or more kinds of drugs or food.
  • Subjects have any history of surgery, trauma that may affect the safety of the study or the intracorporal process of the drug, or have a surgical schedule during the study period.
  • Use of any prescription or over the counter medication within 14 days prior to screening.
  • History of drug abuse within 6 months prior to screening.
  • Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to stop using any tobacco products during the trial period.
  • Consumption of alcohol in excess of 14 units/week within 3 months prior to screening.
  • Consumption excessive amounts of tea, coffee and/or caffeine-rich beverages daily within 3 months prior to screening.
  • Participation in other trial within 3 months prior to screening.
  • Donation or loss of more than 400 mL blood within 3 months prior to screening.
  • Subject (female) is lactating or pregnant.
  • Subject who cannot tolerate venipuncture or have a history of needle and blood sickness.
  • Subject who has special requirements on diet and cannot accept the uniform diet.
  • Subject who has childbearing plan, unwillingness or inability to use effective contraceptives from 2 weeks before the screening to 6 months after the last dosing of the study drug.
  • Any positive test result for Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete.
  • Female subjects with positive pregnancy test results during the screening period or during the study.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Medical Treatment Center

Wuhan, Hubei, 430040, China

Location

MeSH Terms

Interventions

Amphotericin BInjectionsliposomal amphotericin B

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

August 6, 2021

Study Start

June 4, 2020

Primary Completion

September 8, 2020

Study Completion

November 16, 2020

Last Updated

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)