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Invasive Fungal InfectionsPhase 1NCT05749380

Pharmacokinetics and Safety of AmBisome and DKF-5122

A Phase 1 study testing AmBisome and DKF-5122 in people with Invasive Fungal Infections and Neutropenic Fever, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Invasive Fungal Infections, Neutropenic Fever
What is being tested?
AmBisome and DKF-5122
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSouth Korea
Study dates
7 Sep 2020to 28 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 49Show fewer
  • 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
  • Whole blood donation within 60 days or component within 30 days
  • (Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days
  • Grapefruit-containing foods within 7 days
  • Excessive exercise within 7 days
  • Excessive caffeine and alcohol consumption, or a smoker
  • Not eligible due to other reasons at the investigator's discretion
  • Part 2. Healthy subjects
  • Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
  • 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 < 13.0 g/dL
  • Serum Creatinine > 1.25 x UNL
  • eGFR < 90 mL/min/1.73 m2
  • AST or ALT > 1.25 x UNL
  • Total bilirubin > 1.25 x UNL
  • CPK > 1.5 x UNL
  • Systolic blood pressure ≥140 mmHg or ≤90 mmHg
  • Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg
  • Arrhythmia
  • Before the first administration of investigational products
  • Participation to other clinical trials within 6 months
  • Whole blood donation within 60 days or component within 30 days
  • Drugs that induce or inhibit drug metabolism enzymes within 30 days
  • Vaccination within 7 days
  • Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days
  • Grapefruit-containing foods within 7 days
  • Excessive exercise within 7 days
  • Excessive caffeine and alcohol consumption, or a smoker
  • Not eligible due to other reasons at the investigator's discretion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, Seocho-gu, 06591

Other trials in South Korea

About this study

Official title: Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults

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

Being tested
AmBisome, DKF-5122
Medical subject headings
Invasive Fungal Infections, Febrile Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmBisomeDrug

    Reference, dose of 3 mg/kg.

  • DKF-5122Drug

    Test, dose of 3 mg/kg

Study groups in NCT05749380
Study groupRoleWhat they receive
1A(RT)OtherPatients (AmBisome, DKF-5122)
Receives: Drug: AmBisome; Drug: DKF-5122
1B(TR)OtherPatients (DKF-5122, AmBisome)
Receives: Drug: AmBisome; Drug: DKF-5122
2A(RT)OtherHealthy subjects (AmBisome, DKF-5122)
Receives: Drug: AmBisome; Drug: DKF-5122
2B(TR)OtherHealthy subjects (DKF-5122, AmBisome)
Receives: Drug: AmBisome; Drug: DKF-5122

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Liposome encapsulated amphotericin B of healthy adult

    Measured: 0 to 93 hr

  2. AUClast

    Liposome encapsulated amphotericin B of healthy adult

    Measured: 0 to 93 hr

Secondary outcomes (14)

  1. Cmax

    Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  2. AUClast

    Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  3. AUCinf

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  4. tmax

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  5. t1/2

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  6. CL/F

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  7. V/F

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

    Measured: 0 to 93 hr

  8. Cmin,ss

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  9. Cav,ss

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  10. tmax,ss

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  11. t1/2

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  12. PTF (peak to trough fluctuation ratio)

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  13. CLss/F

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

  14. Vd,ss/F

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

    Measured: 0 to 93 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start7 Sep 2020
  3. Primary completion28 Jan 2022
  4. Study completion28 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749380
Sponsor's protocol ID
DKF-5122-BE
Status last verified
Feb 2023
First submitted
16 Feb 2023
Last updated
1 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Feb;48(2):186-195. doi: 10.1016/j.clinthera.2025.12.009. Epub 2026 Jan 8.

    PubMed 41513548

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AmBisome and DKF-5122 in people with Invasive Fungal Infections and Neutropenic Fever, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 0 to 93 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05749380, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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