Alzheimer's Disease (AD)Early Phase 1NCT06489015
Recombinant Human Serum Albumin in the Treatment of Mild-to-moderate AD (Alzheimer's Disease) Exploratory Clinical Trial
A Early Phase 1 study testing Recombinant Human Serum Albumin in people with Alzheimer's Disease (AD), run by Shenzhen Protgen Co., Ltd. at 5 sites in China.
Trial summary
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- Recombinant Human Serum Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesChina
- Study dates
- 27 Aug 2024to 14 Apr 2026
- Phase
- Early 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50 and 85 years (inclusive), with no gender restrictions;
- Meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia";
- The severity of the disease was mild or moderate, that is, 1 ≤ Clinical dementia scale total score (CDR-GS) score ≤ 2;
- Hachinski Ischemia Scale (HIS) ≤ 4;
- Geriatric Depression Scale (GDS) score between 0 and 20 (inclusive);
- Memory impairment present for at least 12 months with evidence of progression;
Show all 12Show fewer
- Previous PET CT/MRI scan can be provided to confirm the diagnosis of AD at the time of screening. We may provide qualified head MRI films or head MRI plain scan and oblique coronal hippocampal scan within 12 months: The likelihood of Alzheimer's disease on MRI was highest when there were fewer than or equal to two infarcts larger than 2 cm in diameter and no infarcts in key areas such as the thalamus, hippocampus, entorhinal cortex, parorhinal cortex, angular gyrus, cortex, or other subcortical gray matter nuclei (Medial Temporal Atrophy Visual Rating Scale [MTA] grade of 2 or greater);
- Female participants must be postmenopausal for at least 24 weeks, have undergone sterilization surgery, or if of childbearing potential, along with fertile males, agree to use effective contraception during the study. Women of childbearing potential or those postmenopausal for less than 24 weeks require a negative pregnancy test at screening;
- If patients were on Alzheimer's medications such as cholinesterase inhibitors, NMDA receptor antagonists, or Oligomannate capsules, or taking other drugs that could affect cognition (e.g., Ginkgo biloba, Ginkgo leaf extract, Vitamin E, Selegiline, Folic acid, Estrogen, traditional Chinese medicines including compound sea snake capsules, Citicoline, Piracetam, Aniracetam, etc.), they must have been on a stable dose for at least 30 days before screening, with the investigator determining suitability and the patient agreeing to maintain this stable dose throughout the trial;
- Patients must have a stable and dependable caregiver or adequate care arrangements (a minimum of 4 days weekly, 2 hours daily), with the caregiver willing to assist in the patient's full participation in the trial, including accompanying them to visits and helping with assessment scales;
- Patients should have an educational level of primary school completion or above, capable of completing cognitive assessments and other tests as required by the protocol;
- Written informed consent obtained.
Who cannot join
- Investigators believe that the main causes of cognitive impairment are frontotemporal dementia, dementia with Lewy bodies, vascular dementia, dementia caused by Parkinson's disease, dementia caused by epilepsy, dementia caused by craniocerebral injury, and dementia related to central nervous system infection and immunity;
- Known history of allergy or allergic reactions to yeast or yeast-derived products, any component of the study formulation, individuals with an allergic constitution (multiple drug or food allergies), a history of severe systemic allergic reactions to biologics, or those deemed unsuitable for trial drug treatment by the investigator;
- Active or historical cardiovascular disorders at screening or conditions deemed inappropriate for human albumin treatment by the investigator, specifically including but not limited to: hypertension (systolic blood pressure >160 mmHg or diastolic >100 mmHg, unless well-controlled with medication and stable in the investigator's judgment), severe anemia, acute cardiac events, significant heart or pulmonary structural diseases, severe arrhythmias, decompensated heart failure (in normal or high volume states), unstable angina, myocardial infarction within 6 months prior to screening, medically treated tachycardia/bradycardia, third-degree atrioventricular block, etc.;
- Active metabolic disorders or history thereof at screening, or concurrent renal impairment deemed unsuitable for serum albumin therapy by the investigator, such as diabetic kidney disease, hyperuricemia-related renal injury, sleep apnea-associated renal damage, hyperlipidemia-induced renal impairment, etc.;
- Presence of severe underlying diseases at screening that the investigator deems inappropriate for study participation, including but not limited to active malignancy, pulmonary edema, bleeding tendencies or active bleeding disorders, uncontrolled infections (including spontaneous bacterial peritonitis), thyroid dysfunction (Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0), etc.;
- Positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), positive for hepatitis C antibody (HCV Ab) with detectable hepatitis C ribonucleic acid (HCV-RNA), positive for human immunodeficiency virus antibody (HIV Ab), or positive for Treponema pallidum (syphilis) antibodies at screening;
Show all 19Show fewer
- Presence of the following laboratory abnormalities at screening:
- Liver function: Alanine transaminase (ALT) >3 times the upper limit of normal (ULN); Aspartate transaminase (AST) >3 ULN; Total bilirubin (TBIL) >1.5 ULN or deemed unsuitable for the trial by the investigator;
- Renal function: Creatinine clearance (Ccr) <50 mL/min (calculated using the Cockcroft-Gault formula: Ccr(mL/min) = [(140 - age) × weight(kg)] / [72 × Scr(mg/dL)], multiplied by 0.85 for females);
- Bone marrow function: Absolute neutrophil count (ANC) <1.5 × 10^9/L; Platelets (PLT) <100 × 10^9/L; Hemoglobin (HGB) <90 g/L;
- Patients had or had a history of a neurological disease at the time of screening, such as a neurological disease with unstable control;
- Patients with coexisting psychiatric conditions, including schizophrenia or other psychiatric conditions, bipolar disorder, and depression or delirium not due to Alzheimer's disease, were assessed by the investigator as being ineligible for the trial;
- Contraindications to MRI scanning, including incompatible cardiac pacemakers/defibrillators, magnetic metal implants, etc.;
- Irreversible visual or auditory impairments preventing completion of assessments related to cognition, neuropsychiatric symptoms, and activities of daily living;
- Alcohol or drug abusers;
- Pregnant or lactating women;
- Received plasma derivatives (including human albumin) within 3 months prior to screening, history of organ transplantation, or planned to undergo invasive procedures or treatments during the study;
- Participated in another clinical trial (excluding non-drug intervention trials) within 30 days prior to the screening visit for this trial or planning to participate in another trial during this study;
- The investigator judges that the AD patient is unlikely to complete the trial, such as poor adherence to medication or scheduled visits.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Clinical Medical College & Affiliated Hospital Of Jiujiang University
Jiujiang, Jiangxi, 332000
Luoyang Third People's Hospital
Luoyang, Henan, 471002
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Wuhan Union Hospital of China
Wuhan, Hubei, 430000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: An Open-label, Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild-to-moderate Alzheimer's Disease
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD).
Read the detailed description
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 participants who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- Recombinant Human Serum Albumin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Serum AlbuminDrug
Each group receives the investigational drug (recombinant human serum albumin), with the distinction being the variation in dosing.
| Study group | Role | What they receive |
|---|---|---|
| 20g dose group | Experimental | Administered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) Receives: Drug: Recombinant Human Serum Albumin |
| 30g dose group | Experimental | Administered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) Receives: Drug: Recombinant Human Serum Albumin |
| 40g dose group | Experimental | Administered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) Receives: Drug: Recombinant Human Serum Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The primary objective of the trial was to evaluate safety according to the type, incidence, and severity of adverse events, which were graded with the use of the NCI CTCAE V5.0.
Measured: About week 29 or 41（It depends on whether the participant enters the extention treatment period）
Secondary outcomes (5)
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) score at W25 post-treatment.
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is an instrument used to assess cognitive function in individuals with Alzheimer's disease or other forms of dementia. The scale ranges from 0 to 75, with lower scores indicating better cognitive function and higher scores indicating more severe cognitive impairment. Therefore, the lower the score on the ADAS-Cog, the better the cognitive performance of the individual being assessed. Conversely, a higher score indicates greater cognitive decline. The minimum possible score on the ADAS-Cog is 0, and the maximum possible score is 75.
Measured: At Week 25
The changes in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) scores from baseline at Weeks 7, 16, 29 (if applicable), 37 (if applicable), and 41 (if applicable) post-treatment.
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is an instrument used to assess cognitive function in individuals with Alzheimer's disease or other forms of dementia. The scale ranges from 0 to 75, with lower scores indicating better cognitive function and higher scores indicating more severe cognitive impairment. Therefore, the lower the score on the ADAS-Cog, the better the cognitive performance of the individual being assessed. Conversely, a higher score indicates greater cognitive decline. The minimum possible score on the ADAS-Cog is 0, and the maximum possible score is 75.
Measured: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Clinical Dementia Rating Scale - Global Score (CDR-GS) from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) following treatment initiation.
The Clinical Dementia Rating - Global Score (CDR-GS) is a tool used by healthcare professionals to assess the severity of dementia in patients. The CDR-GS has a range from 0 to 3, with 0 representing no dementia, 0.5 indicating very mild dementia, 1 indicating mild dementia, 2 indicating moderate dementia, and 3 indicating severe dementia.
Therefore, the lower the score on the CDR-GS, the better the cognitive and functional abilities of the individual being assessed. Conversely, a higher score indicates more severe dementia. The minimum possible score on the CDR-GS is 0, and the maximum possible score is 3.
Measured: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Neuropsychiatric Inventory (NPI) scores from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) after the commencement of treatment.
The Neuropsychiatric Inventory (NPI) is a tool used to evaluate neuropsychiatric symptoms in individuals with dementia. A lower score on the NPI indicates fewer or less severe neuropsychiatric symptoms, while a higher score suggests more frequent or severe symptoms. Thus, a lower NPI score is generally considered to be a better outcome. The minimum possible score is 0, and the maximum possible score is 144.
Measured: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) ability assessment scale scores from baseline
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) is a tool designed to measure the functional ability of individuals with Alzheimer's disease. The ADCS-ADL has a range from 0 to 78, where 0 indicates complete dependence and 78 indicates complete independence. Higher scores on the ADCS-ADL indicate better functional status and ability to perform daily activities independently.ng the start of treatment.
Measured: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start27 Aug 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Protgen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xia Li, Ph.D, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489015
- Sponsor's protocol ID
- rHSA 2024-01
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild-to-moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06489015
- Acronym / sponsor ID
- rHSA 2024-01
- Conditions
- Alzheimer's Disease (AD)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shenzhen Protgen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 5 Jul 2024 (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.
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD).
Detailed description
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 participants who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20g dose group | Experimental | Drug: Recombinant Human Serum AlbuminAdministered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) |
| 30g dose group | Experimental | Drug: Recombinant Human Serum AlbuminAdministered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) |
| 40g dose group | Experimental | Drug: Recombinant Human Serum AlbuminAdministered intravenously once every 3 weeks, until 25 weeks (or 37 weeks if the treatment period was extended) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged between 50 and 85 years (inclusive), with no gender restrictions;
- Meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia";
- The severity of the disease was mild or moderate, that is, 1 ≤ Clinical dementia scale total score (CDR-GS) score ≤ 2;
- Hachinski Ischemia Scale (HIS) ≤ 4;
- Geriatric Depression Scale (GDS) score between 0 and 20 (inclusive);
Key exclusion criteria (19 listed)
- Investigators believe that the main causes of cognitive impairment are frontotemporal dementia, dementia with Lewy bodies, vascular dementia, dementia caused by Parkinson's disease, dementia caused by epilepsy, dementia caused by craniocerebral injury, and dementia related to central nervous system infection and immunity;
- Known history of allergy or allergic reactions to yeast or yeast-derived products, any component of the study formulation, individuals with an allergic constitution (multiple drug or food allergies), a history of severe systemic allergic reactions to biologics, or those deemed unsuitable for trial drug treatment by the investigator;
- Active or historical cardiovascular disorders at screening or conditions deemed inappropriate for human albumin treatment by the investigator, specifically including but not limited to: hypertension (systolic blood pressure >160 mmHg or diastolic >100 mmHg, unless well-controlled with medication and stable in the investigator's judgment), severe anemia, acute cardiac events, significant heart or pulmonary structural diseases, severe arrhythmias, decompensated heart failure (in normal or high volume states), unstable angina, myocardial infarction within 6 months prior to screening, medically treated tachycardia/bradycardia, third-degree atrioventricular block, etc.;
- Active metabolic disorders or history thereof at screening, or concurrent renal impairment deemed unsuitable for serum albumin therapy by the investigator, such as diabetic kidney disease, hyperuricemia-related renal injury, sleep apnea-associated renal damage, hyperlipidemia-induced renal impairment, etc.;
- Presence of severe underlying diseases at screening that the investigator deems inappropriate for study participation, including but not limited to active malignancy, pulmonary edema, bleeding tendencies or active bleeding disorders, uncontrolled infections (including spontaneous bacterial peritonitis), thyroid dysfunction (Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0), etc.;
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 |
|---|---|---|
| Recombinant Human Serum AlbuminEach group receives the investigational drug (recombinant human serum albumin), with the distinction being the variation in dosing. | Drug | 20g dose group, 30g dose group, 40g dose group |
Primary outcome
Adverse Events
Time frame: About week 29 or 41（It depends on whether the participant enters the extention treatment period）
The primary objective of the trial was to evaluate safety according to the type, incidence, and severity of adverse events, which were graded with the use of the NCI CTCAE V5.0.
5 secondary outcomes
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) score at W25 post-treatment.
Time frame: At Week 25
The changes in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) scores from baseline at Weeks 7, 16, 29 (if applicable), 37 (if applicable), and 41 (if applicable) post-treatment.
Time frame: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Clinical Dementia Rating Scale - Global Score (CDR-GS) from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) following treatment initiation.
Time frame: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Neuropsychiatric Inventory (NPI) scores from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) after the commencement of treatment.
Time frame: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
The changes in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) ability assessment scale scores from baseline
Time frame: At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
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 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease (AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Xia Li, Ph.D study director
Shanghai Mental Health Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Recombinant Human Serum Albumin in people with Alzheimer's Disease (AD), run by Shenzhen Protgen Co., Ltd. at 5 sites 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 12 inclusion and 19 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Adverse Events (time frame: About week 29 or 41（It depends on whether the participant enters the extention treatment period）). 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 25 Aug 2026.