Bioequivalence of Amphotericin B Liposome for Injection

NCT05913921 | Completed Phase 1

• 1 other identifier: HC1507-004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Bioequivalence based on Cmax

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

  predose to 216 hours post dose

• Bioequivalence based on AUC0-t

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

  predose to 216 hours post dose

• 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 to 216 hours post dose

Secondary Outcomes (3)

• Cmax

  predose to 216 hours post dose

• AUC0-t

  predose to 216 hours post dose

• AUC0-∞

  predose to 216 hours post dose

Study Arms (2)

Sequence TR

EXPERIMENTAL

16 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 injection; Drug: AmBisome

Sequence RT

EXPERIMENTAL

16 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 injection; Drug: AmBisome

Interventions

Amphotericin B liposome for injection DRUG

IV infusion, 2.0 mg/kg

Also known as: the test product

Sequence RT; Sequence TR

AmBisome DRUG

IV infusion, 2.0 mg/kg

Also known as: the reference product

Sequence RT; Sequence TR

Eligibility Criteria

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

You may qualify if:

• Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
• The subjects can communicate well with the investigators and complete the trial according to protocol.
• Sex: male or female subjects.
• Age of 18 - 55 years (inclusive).
• BMI: 18.6-28.5 kg/m\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.

You may not qualify if:

• Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.
• Subjects with the following diseases of clinical significance (including but not limited to diseased related to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychiatric system, otorhinolaryngology).
• Subjects with liver and kidney diseases that affect the pharmacokinetic of drugs.
• Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
• Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory examination (including but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and creatinine above the upper limit of normal).
• Subjects with a history of hepatitis B, hepatitis C, AIDS, syphilis and/or abnormalities in one or more of the four tests for infectious diseases with clinical significance.
• Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration.
• Use of any drug within 14 days prior to initial administration (except for topical drugs with local effects).
• Use of any investigational medicinal product within 3 months prior to initial administration.
• A history of drug abuse, and/or drug use within 3 months prior to screening, and/or habitual use of any drug, including Chinese herbs.
• Positive urine drug screening.
• Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization.
• Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
• Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, and/or do not agree that tea, coffee and/or caffeinated foods, grapefruit (grapefruit) and/or grapefruit juice (grapefruit juice), and/or products containing opium poppy are prohibited during hospitalization.
• Those who have a birth plan (including sperm donation and egg donation) and/or do not agree to take effective contraceptive methods (non-drug during the trial period) within 3 months after signing informed consent form.

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Haikou people's Hospital

Haikou, Hainan, China

Location

MeSH Terms

Interventions

Amphotericin B; Injections; liposomal amphotericin B

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• XiaoAi He

  Haikou People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 22, 2023
• Study Start: June 2, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)