NCT05749380

Brief Summary

The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2020

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

September 7, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

February 16, 2023

Last Update Submit

February 26, 2023

Conditions

Invasive Fungal InfectionsNeutropenic Fever

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Liposome encapsulated amphotericin B of healthy adult

    0 to 93 hr

  • AUClast

    Liposome encapsulated amphotericin B of healthy adult

    0 to 93 hr

Secondary Outcomes (14)

  • Cmax

    0 to 93 hr

  • AUClast

    0 to 93 hr

  • AUCinf

    0 to 93 hr

  • tmax

    0 to 93 hr

  • t1/2

    0 to 93 hr

  • +9 more secondary outcomes

Study Arms (4)

1A(RT)

OTHER

Patients (AmBisome, DKF-5122)

Drug: AmBisomeDrug: DKF-5122

1B(TR)

OTHER

Patients (DKF-5122, AmBisome)

Drug: AmBisomeDrug: DKF-5122

2A(RT)

OTHER

Healthy subjects (AmBisome, DKF-5122)

Drug: AmBisomeDrug: DKF-5122

2B(TR)

OTHER

Healthy subjects (DKF-5122, AmBisome)

Drug: AmBisomeDrug: DKF-5122

Interventions

AmBisomeDRUG

Reference, dose of 3 mg/kg.

1A(RT)1B(TR)2A(RT)2B(TR)
DKF-5122DRUG

Test, dose of 3 mg/kg

1A(RT)1B(TR)2A(RT)2B(TR)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1. Patients
  • Age 19 years and older
  • Empirical therapy for presumed fungal infection in febrile, neutropenic patients
  • Voluntarily decided to participate in the study and signed the informed consent form
  • Having contraception during the study
  • Part 2. Healthy subjects
  • Age 19 to 45 years
  • Body weight 55 kg or more, within ±20% of the ideal body weight
  • Having no congenital or chronic disease within the last 5 years.
  • Voluntarily decided to participate in the study and signed the informed consent form
  • Having contraception during the study

You may not qualify if:

  • Part 1. Patients
  • Clinically significant conditions that may affect the pharmacokinetics of amphotericin
  • History of diseases that may affect the pharmacokinetics of amphotericin
  • History of drug abuse
  • History of hypersensitivity to ingredients of investigational products
  • Unable to maintain proper contraception
  • Pregnant or breast-feeding
  • The following laboratory test results at screening
  • Hemoglobin \< 8.0 g/dL
  • Serum Creatinine \> 2x the UNL
  • AST or ALT \> 10x UNL
  • Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg
  • Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg
  • Before the first administration of investigational products
  • Participation to other clinical trials within 6 months
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

Location

Related Publications (1)

  • Han S, Yim DS, Han S, Choi S, Cho SY, Lee R, Nho D, Baek HJ, Lee DG. Pharmacokinetic Equivalence of AmphosomTM, a Newly Developed Liposomal Amphotericin B, to AmbisomeⓇ. Clin Ther. 2026 Jan 8:S0149-2918(25)00419-9. doi: 10.1016/j.clinthera.2025.12.009. Online ahead of print.

    PMID: 41513548DERIVED

MeSH Terms

Conditions

Invasive Fungal InfectionsFebrile Neutropenia

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsNeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Design

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

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 1, 2023

Study Start

September 7, 2020

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)