Invasive Fungal InfectionsNCT06983665
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
A study testing Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Reference product (AmBisome®, Astellas Pharma US Inc.) in people with Invasive Fungal Infections and Neutropenic Fever, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- What is being tested?
- Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Reference product (AmBisome®, Astellas Pharma US Inc.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 9 Mar 2026
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 23Show fewer
- 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;
- Subjects who have used any medications within 28 days prior to screening that affect the absorption and metabolism of the investigational drug (including hepatic enzyme inhibitors, inducers, or those that alter the gastrointestinal environment), or interact with the investigational drug (e.g., corticosteroids, adrenocorticotropic hormone drugs, pyrrolizidine drugs (e.g., ketoconazole, miconazole, clotrimazole, fluconazole), skeletal muscle relaxants, antineoplastic agents, digitalis glycosides, flucytosine, or other nephrotoxic drugs), and who, as determined by the Investigator, are not suitable to participate in the study;
- Subjects who have used any prescription drugs within 14 days prior to screening or any over-the-counter drugs, Chinese herbal medicines or health products within 7 days prior to screening, except for topical drugs that act on a particular place of body;
- Subjects who are unable to avoid consuming xanthine-rich beverages (coffee, tea, etc.) or foods (chocolate, animal liver, etc.), or consuming fruits or juices that may affect metabolism (grapefruit, pomelo, mango, dragon fruit, etc.) or iodine-rich foods (seaweed, kelp, etc.) during a period from 48 hours pre-dose to the end of the study, or subjects who have other factors that affect drug absorption, distribution, metabolism and excretion;
- Subjects who have taken strenuous exercise within 48 hours prior to screening;
- Subjects who have special requirements for diet and cannot follow the diet provided during the study;
- Subjects who have difficulty in venous blood collection or a history of fear of needles or hemophobia;
- Female subjects who are breastfeeding or have a positive pregnancy test result during the screening period or course of the trial;
- Subjects who, as determined by the Investigator, are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose, Randomized, Open-Label, Two-Sequence, Two-Period, Double-Crossover, Bioequivalence Study of Liposomal Amphotericin B for Injection in Healthy Chinese Subjects
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.
Read the detailed description
The study involves 42 healthy subjects (male and female) aged 18-55 years. Subjects will be randomized into two groups (TR and RT) and receive either the test or reference product in period 1, followed by a 92-day washout period before crossing over to the other product in period 2. Blood samples will be collected at 25 time points for pharmacokinetic analysis.
- Being tested
- Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.), Reference product (AmBisome®, Astellas Pharma US Inc.)
- Medical subject headings
- Invasive Fungal Infections, Febrile Neutropenia, Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)Drug
Also called Test product.
Single intravenous administration of 2.0 mg/kg in each period.
Reference product (AmBisome®, Astellas Pharma US Inc.)Drug
Also called Reference product.
Single intravenous administration of 2.0 mg/kg in each period.
| Study group | Role | What they receive |
|---|---|---|
| Group I, Liposomal amphotericin B for injection | Experimental | Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) Receives: Drug: Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) |
| Group II, AmBisome® | Experimental | Reference product (AmBisome®, Astellas Pharma US Inc.) Receives: Drug: Reference product (AmBisome®, Astellas Pharma US Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 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
90% Cl of Cmax of free amphotericin B
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC0-t of free amphotericin B
90% Cl of AUC0-t of free amphotericin B
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC0-∞ of free amphotericin B
90% Cl of AUC0-∞ of free amphotericin B
Measured: 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
90% Cl of AUC0-10h of liposome-encapsulated amphotericin B
Measured: 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
90% Cl of AUC10-last of liposome-encapsulated amphotericin B
Measured: 10 hours post formal dose to 1320 hours post formal dose
Partial exposure indicators (AUC0-24h)
90% Cl of AUC0-24h of free amphotericin B
Measured: 0 h before safe dose and 0 h before formal dose to 24 hours post formal dose
Partial exposure indicators (AUC24-last) of free amphotericin B
90% Cl of AUC24-last of free amphotericin B
Measured: 24 hours post formal dose to 1320 hours post formal dose
AUC%Extrap
Descriptive analysis
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Tmax
Non-parametric test
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
t1/2
Descriptive analysis
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
λz
Descriptive analysis
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
F
Descriptive analysis
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start25 May 2025
- Primary completion10 Nov 2025
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Study director, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983665
- Sponsor's protocol ID
- JN-0035-BE01
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Randomized, Open-Label, Two-Sequence, Two-Period, Double-Crossover, Bioequivalence Study of Liposomal Amphotericin B for Injection in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06983665
- Acronym / sponsor ID
- JN-0035-BE01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 May 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study involves 42 healthy subjects (male and female) aged 18-55 years. Subjects will be randomized into two groups (TR and RT) and receive either the test or reference product in period 1, followed by a 92-day washout period before crossing over to the other product in period 2. Blood samples will be collected at 25 time points for pharmacokinetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I, Liposomal amphotericin B for injection | Experimental | Drug: Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) |
| Group II, AmBisome® | Experimental | Drug: Reference product (AmBisome®, Astellas Pharma US Inc.)Reference product (AmBisome®, Astellas Pharma US Inc.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)Also: Test product.Single intravenous administration of 2.0 mg/kg in each period. | Drug | Group I, Liposomal amphotericin B for injection |
| Reference product (AmBisome®, Astellas Pharma US Inc.)Also: Reference product.Single intravenous administration of 2.0 mg/kg in each period. | Drug | Group II, AmBisome® |
Primary outcome
Bioequivalence based on Cmax of liposome-encapsulated
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
90% Cl of Cmax of liposome-encapsulated amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%
Bioequivalence based on AUC0-t of liposome-encapsulated
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
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%
Bioequivalence based on AUC0-∞ of liposome-encapsulated
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
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%
12 secondary outcomes
Cmax of free amphotericin B
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC0-t of free amphotericin B
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC0-∞ of free amphotericin B
Time frame: 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
Time frame: 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
Time frame: 10 hours post formal dose to 1320 hours post formal dose
Partial exposure indicators (AUC0-24h)
Time frame: 0 h before safe dose and 0 h before formal dose to 24 hours post formal dose
Partial exposure indicators (AUC24-last) of free amphotericin B
Time frame: 24 hours post formal dose to 1320 hours post formal dose
AUC%Extrap
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Tmax
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
t1/2
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
λz
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
F
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Invasive Fungal Infections
Not yet recruitingPhase 2
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
Coccidioidomycosis, Disseminated Fungal Infection
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Not yet recruitingObservational study
mNGS for IFD in Patients With Hematological Malignancies
Hematological Malignancies, Invasive Fungal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Wen study director
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Reference product (AmBisome®, Astellas Pharma US Inc.) in people with Invasive Fungal Infections and Neutropenic Fever, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
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 5 inclusion and 23 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 27 May 2026. 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 China. 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.
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?
Bioequivalence based on Cmax of liposome-encapsulated (time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.