Human Bioequivalence Study of Liposomal Amphotericin B for Injection

NCT06983665 | Active Not Recruiting

• 1 other identifier: JN-0035-BE01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome®) in healthy Chinese subjects. Secondary objectives include safety evaluation.

Conditions

Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (3)

• Bioequivalence based on Cmax of liposome-encapsulated

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

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• Bioequivalence based on AUC0-t of liposome-encapsulated

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

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• Bioequivalence based on AUC0-∞ of liposome-encapsulated

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

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

Secondary Outcomes (12)

• Cmax of free amphotericin B

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• AUC0-t of free amphotericin B

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• AUC0-∞ of free amphotericin B

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• Partial exposure indicators (AUC0-10h) of liposome-encapsulated amphotericin B

  0 h before safe dose and 0 h before formal dose to 10 hours post formal dose

• Partial exposure indicators (AUC10-last) of liposome-encapsulated amphotericin B

  10 hours post formal dose to 1320 hours post formal dose

Study Arms (2)

Group I, Liposomal amphotericin B for injection

EXPERIMENTAL

Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)

Drug: Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)

Group II, AmBisome®

EXPERIMENTAL

Reference product (AmBisome®, Astellas Pharma US Inc.)

Drug: Reference product (AmBisome®, Astellas Pharma US Inc.)

Interventions

Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) DRUG

Single intravenous administration of 2.0 mg/kg in each period.

Also known as: Test product.

Group I, Liposomal amphotericin B for injection

Reference product (AmBisome®, Astellas Pharma US Inc.) DRUG

Single intravenous administration of 2.0 mg/kg in each period.

Also known as: Reference product.

Group II, AmBisome®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary participate in the clinical trial, with the ability to sign an informed consent form (ICF) and have a full understanding of trial contents, process, and potential adverse reactions, and be able to understand and adhere to the trial procedures;
• Chinese male and female subjects aged 18 to 55 years old (inclusive);
• Male subjects with weight no less than 50.0 kg, and female subjects with weight no less than 45.0 kg. Body mass index (BMI) = weight/height2 (kg/m2). BMI is 18.6-28.5 kg/m2 (both inclusive);
• At screening, subjects' vital signs, physical examinations, laboratory tests, and electrocardiogram (ECG) results are normal, or abnormal but clinically insignificant as determined by the Investigator;
• Subjects (including male subjects) have adopted effective contraceptive measures within 14 days prior to the first dosing and are willing to refrain from pregnancy, donating sperm or eggs, and voluntarily use effective contraceptive measures (non-pharmacological contraception during the trial) from the time of signing the informed consent form until 6 months after the last dose.

You may not qualify if:

• Subjects with chronic or severe diseases of the cardiovascular, hepatic, renal, respiratory, hematological and lymphatic, endocrine, immune, mental and nervous, gastrointestinal, metabolic, and skeletal systems, who, as determined by the Investigator, are not suitable to participate in the study;
• Subjects with clinically significant abnormalities as determined by the Investigator, including physical examination, vital signs, ECG or clinical laboratory tests, especially abnormalities in hepatic and renal functions (subjects with serum creatinine, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) above the upper limit of normal (ULN));
• Subjects with existing allergic diseases (nettle rash, eczema, etc.), or an atopic constitution (e.g. allergies to two or more medications, foods such as milk, or pollen), or a known history of hypersensitivity to any component of conventional amphotericin B formulations or liposomal amphotericin B formulations, including the active ingredient or any excipients in this product (such as soybean oil), peanuts or soy;
• Subjects who are positive for any one or more of the following tests: Hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, Treponema pallidum specific antibody and human immunodeficiency virus (HIV) antigen/antibody;
• Subjects with a history of drug abuse;
• Subjects who are positive for urine drug screening (methamphetamine (meth), MDMA (ecstasy), THC (cannabis), morphine, ketamine);
• Regular drinkers within 3 months prior to screening, defined as subjects who drink more than 14 units of alcohol per week (1 unit ≈ 285 mL of beer with 3.5% ABV or 25 mL of spirits with 40% ABV or 85 mL of wine with 10% ABV), or subjects who cannot stop drinking or consuming any alcoholic products throughout the study;
• Subjects who are positive for breath alcohol test;
• Subjects with excessive daily consumption of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) within the 3 months prior to screening;
• Subjects with a daily cigarette consumption of \> 5 cigarettes/day within 3 months prior to screening, or who cannot discontinue any tobacco-based products, nicotine products, or e-cigarette products throughout the study;
• Subjects with a history of surgery within 3 months prior to screening, or planned surgery, dental procedures, or hospitalization during the study period;
• Subjects who have donated blood or experienced massive blood loss (\> 400 mL) within 3 months prior to screening, or donated platelets ≥2 therapeutic doses (1 therapeutic dose = 12 U of platelets) within 1 month prior to screening;
• Subjects who have participated in and received treatment in any drug or medical device clinical study within 3 months prior to screening;
• Subjects who have received any live vaccine within 3 months prior to screening, or any COVID-19 vaccine within 2 weeks prior to screening, or who are scheduled to be vaccinated within one month after study completion;
• Subjects who have used any oral contraceptives within 30 days prior to screening or any long-acting estrogen and/or progestin injections and/or implantable contraceptive devices within 6 months prior to screening;

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead

Study Sites (1)

Jinan Central Hospital, No.105, Jiefang Road,

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections; Febrile Neutropenia; Leishmaniasis, Visceral

Interventions

liposomal amphotericin B; Injections; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Qing Wen

  Jinan Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: May 25, 2025
• Primary Completion: November 10, 2025
• Study Completion: April 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)