Parkinson's Disease (PD)Phase 2NCT07647614
A Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for Parkinson's Disease
A Phase 2 study testing 60 milligrams of ENERGI-F705 Tablets and 120 milligrams of ENERGI-F705 Tablets in people with Parkinson's Disease (PD), run by Energenesis Biomedical Co., Ltd. at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to learn if this study drug, ENERGI-F705 Tablets, is safe and works to treat participants who have Parkinson's disease and are currently on standard-of-care antiparkinsonian medications. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- 60 milligrams of ENERGI-F705 Tablets and 120 milligrams of ENERGI-F705 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Dec 2026to 1 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject is eligible for the study if all of the following apply:
- With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit)
- Has been diagnosed with idiopathic Parkinson's disease (defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's disease) for ≥ 2 years prior to or at Visit 2 (Day 1)
- Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit)
- With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit)
- Without motor complications, which is defined as a score of 2 or less on the MDS-UPDRS Part IV score at Visit 1 (Screening Visit)
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- Has received a stable standard-of-care regimen, as determined by the investigator, during the 12 weeks prior to Visit 2 (Day 1) and is currently on the following antiparkinsonian medications with an average levodopa equivalent daily dose (LEDD) of ≥ 300 mg during the same period, including:
- Levodopa
- Catechol-O-methyl transferase (COMT) inhibitors
- Monoamine Oxidase-B (MAO-B) inhibitors
- Ergot-derived dopamine receptor agonists
- Non ergot-derived dopamine receptor agonists
- Others with established levodopa-conversion factors
- Has adequate indices as follows at Visit 1 (Screening Visit):
- Hematology: white blood cells (WBC) should be ≥ 3,000 cells/μL, platelet count should be ≥ 80,000 per μL of blood
- Coagulation: prothrombin time, international normalized ratio (INR), and activated partial thromboplastin time (APTT), all of which should be ≤ 1.5 times the upper limit of the normal range (ULN)
- Liver function: serum total bilirubin should be ≤ 1.5 times ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤ 3 times ULN
- Renal function: an estimated glomerular filtration rate (eGFR) should be ≥ 60 mL/min/1.73m2, calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Is willing and able to comply with all required study visits and follow-ups required by this protocol
- Understands the study procedures and provided written informed consent (including through use of a legally authorized representative, if necessary)
- Is able to complete all subject-reported outcome measures
Who cannot join
- Any subject meeting any of the exclusion criteria will be excluded from study participation:
- Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism
- Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1):
- Deep brain stimulation
- Pallidotomy
- Thalamotomy
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- Other procedures that may affect motor function
- With Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 (Screening Visit)
- With a lifetime history of significant psychiatric disorder (e.g., alcohol use disorder, drug abuse, or suicide attempt), which in the investigator's opinion, may interfere with study participation
- With history of malignancy or current malignancy within 2 years prior to or at Visit 2 (Day 1)
- With ongoing or a documented history of within 2 years prior to or at Visit 2 (Day 1) of acute diseases or severe medical conditions, including:
- Cardiovascular (myocardial infarction, congestive heart failure, New York Heart Association Grade III or IV)
- Pulmonary (severe chronic obstructive pulmonary disease, pulmonary hypertension, or other clinically significant respiratory conditions)
- Current severe infections, medical history, physical examination findings, or laboratory examination abnormality that in the investigators' opinion are not in stable condition and participating in the study could interfere with the results of the trial or adversely affect the safety of the subject
- Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:
- Typical antipsychotics (e.g., Haloperidol, Chlorpromazine)
- Atypical antipsychotics (e.g., Risperidone, Quetiapine or Clozapine)
- With clinically significant gastrointestinal disorders that may affect oral drug absorption or tolerability (e.g., inflammatory bowel disease within 12 weeks prior to or at Visit 2 (Day 1) or relevant gastrointestinal surgery recorded on a lifetime basis)
- With a history of gout or urolithiasis, or treatment with medications for gout or urolithiasis, within 2 years prior to or at Visit 2 (Day 1)
- With known hypersensitivity to any component of the investigational product
- Has participated in another clinical trial involving an investigational product, medical device, or surgical procedure within 4 weeks prior to Visit 1 (Screening Visit)
- Note: Subjects enrolled in non-interventional clinical trials will be eligible.
- Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Visit 2 (Day 1)
- Note: Female subjects with any of following conditions are considered not with childbearing potential
- With menopause ≥ 1 year
- Prior surgical procedures resulting in infertility
- Documented follicle-stimulating hormone or luteinizing hormone levels consistent with postmenopausal status
- Female subjects with childbearing potential or male subjects with partners of childbearing potential who refuse to use highly effective contraceptives from signing informed consent until the end of study (EOS) or early termination (ET) visit
- Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
- Is an employee of the investigator's site, the sponsor, or its delegate (e.g., contract research organization) who is directly involved in the conduct of the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
Department of Neurology, Shuang Ho Hospital
New Taipei City
Yifang Cheng, Ph.D., +886-2-26270835, ct@energenesis-biomedical.com
Taipei Medical University Hospital
Taipei
Yifang Cheng, PhD, +886-2-26270835, ct@energenesis-biomedical.com
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets in Combination With Standard of Care for Treating Subjects With Parkinson's Disease
The goal of this clinical trial is to learn if this study drug, ENERGI-F705 Tablets, is safe and works to treat participants who have Parkinson's disease and are currently on standard-of-care antiparkinsonian medications. The main question it aims to answer is:
Does ENERGI-F705 Tablets work to treat Parkinson's disease when used with standard-of-care treatment?
Read more
Investigators will compare the three treatment groups, high-dose ENERGI-F705 Tablets (120 milligrams twice daily), low-dose ENERGI-F705 Tablets (60 milligrams twice daily), and placebo tablets (a look-alike substance that contains no drug), to see if ENERGI-F705 Tablets work to treat Parkinson's disease.
Participants will:
- Take the study drugs twice a day for 72 weeks in the treatment group
- Take routine use of standard-of-care antiparkinsonian medications throughout the study
- Visit the outpatient department at scheduled visits, ranging from Day 1 to approximately every 1 to 4 weeks thereafter, for checkups and tests
- Conditions
- Parkinson's Disease (PD)
- Being tested
- 60 milligrams of ENERGI-F705 Tablets, Placebo tablets, 120 milligrams of ENERGI-F705 Tablets
- Keywords
- Phase II, Randomized, Double blind, ENERGI, Parkinson' disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 milligrams of ENERGI-F705 TabletsDrug
Tablets will be taken orally twice a day
Placebo tabletsDrug
Tablets will be taken orally twice a day.
120 milligrams of ENERGI-F705 TabletsDrug
Tablets will be taken orally twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose ENERGI-F705 Tablets | Experimental | 60 milligrams of ENERGI-F705 Tablets Receives: Drug: 60 milligrams of ENERGI-F705 Tablets |
| High-dose ENERGI-F705 Tablets | Experimental | 120 milligrams of ENERGI-F705 Tablets Receives: Drug: 120 milligrams of ENERGI-F705 Tablets |
| Placebo tablets | Placebo comparator | Placebo tablets Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse events (AE) and serious adverse events (SAE)
All AEs and SAEs will be assessed following National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: From Day 1 to Week 76
Secondary outcomes (15)
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score
MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements.
Measured: Baseline to Week 72
MDS-UPDRS Part IV score
MDS-UPDRS Part IV is a scale used by the investigator to evaluate the motor complications in Parkinson's disease. The total score ranges from 0 to 24 with the higher score indicating greater impact on the daily life due to motor complications.
Measured: Baseline to Week 72
Sum of MDS-UPDRS Part I score, MDS-UPDRS Part II score and MDS-UPDRS Part III score
- MDS-UPDRS Part I is a scale, consisting of Part IA (conducted by healthcare professionals) and Part IB (participant's self-assessment), to assess how non-motor symptoms impact daily living. The total score ranges from 0 to 52. The higher score indicates more non-motor symptoms or greater impact on the activities of daily living due to non-motor symptoms.
- MDS-UPDRS Part II is a participant's self-assessment to observe how motor symptoms affect your daily living. The total score ranges from 0 to 52. The higher score indicates more motor symptoms or greater impact on the activities of daily living.
- MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements.
Measured: Baseline to Week 72
Proportion of participants with 3-point or more increase in MDS-UPDRS Part III score
MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements.
Measured: Baseline to Week 72
Time to onset of motor complication
The motor complication events are collected from the MDS-UPDRS Part IV, a scale to evaluate the motor complication in Parkinson's disease. The total score ranges from 0 to 24 with the higher score indicating greater impact on the daily life due to motor complications.
Measured: From Day 1 to Week 72
Non-motor symptoms scale (NMSS) total score
NMSS is a scale to assess non-motor symptoms in Parkinson's disease. It contains 9 subdomains and the total score ranges from 0 to 360. The higher score indicates greater burden of non-motor symptoms.
Measured: Baseline to Week 72
Parkinson's Disease Questionnaire-39 (PDQ-39) total score
PDQ-39 score is to assess the health-related quality of life with Parkinson's disease. The total score is transformed into a percentage score between 0 to 100 with higher percentage indicating worsen health-related quality of life due to Parkinson's disease.
Measured: Baseline to Week 72
Modified Hoehn and Yahr stage
Modified Hoehn and Yahr stage is a scale to evaluate severity of Parkinson's disease in 8 stages. The staging ranges from Stage 0 (No sings of disease) to Stage 5 (Wheelchair bound or bedridden unless aided).
Measured: Baseline to Week 72
Levodopa equivalent daily dose (LEDD) of antiparkinsonian medications
The doses of antiparkinsonian medications will be converted into levodopa equivalent daily dose (LEDD, mg).
Measured: Baseline to Week 72
Time to the first LEDD adjustment
It refers to the changes in LEDD amount (defined as a ≥10% change in LEDD).
Measured: From Day 1 to Week 72
Number of participants with abnormalities in vital signs
Vital signs measurement consist of systolic and diastolic blood pressure, respiratory rate, pulse rate, and body temperature.
Measured: Baseline to Week 76
Number of participants with abnormalities in laboratory examination results
Laboratory examinations consist of the followings:
- Hematology: hemoglobin, hematocrit, red blood cell (RBC), platelet, white blood cell (WBC) with differential counts, prothrombin time, international normalized ratio (INR), and activated partial thromboplastin time (APTT)
- Biochemistry: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), uric acid, blood urea nitrogen (BUN), serum albumin, creatinine, and estimated glomerular filtration rate (eGFR)
- Urinalysis: color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, and microscopic examination of urine sediment
Measured: Baseline to Week 76
Number of participants with toxicity grade change for the laboratory examination results
Toxicity grading will be assessed according to the NCI-CTCAE version 6.0.
Measured: Baseline to Week 76
Number of participants with abnormalities in physical examination
Physical examinations include general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems if applicable for describing the status of the subject's health.
Measured: Baseline to Week 76
Number of participants with transition of electrocardiogram results
The results of ventricular rate, PR interval, QRS interval, QT interval, RR interval, and QTcB will be recorded.
Measured: Baseline to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tu-Hsueh YEH, M.D., Principal investigator, Department of Neurology, Taipei Medical University HospitalChien-Tai Hong, M.D., Principal investigator, Department of Neurology, Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647614
- Sponsor's protocol ID
- ENERGI-F705-02
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets in Combination With Standard of Care for Treating Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07647614
- Acronym / sponsor ID
- ENERGI-F705-02
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Phase II, Randomized, Double blind, ENERGI, Parkinson' disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 15 Jun 2026 (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.
The goal of this clinical trial is to learn if this study drug, ENERGI-F705 Tablets, is safe and works to treat participants who have Parkinson's disease and are currently on standard-of-care antiparkinsonian medications. The main question it aims to answer is:
Does ENERGI-F705 Tablets work to treat Parkinson's disease when used with standard-of-care treatment?
Investigators will compare the three treatment groups, high-dose ENERGI-F705 Tablets (120 milligrams twice daily), low-dose ENERGI-F705 Tablets (60 milligrams twice daily), and placebo tablets (a look-alike substance that contains no drug), to see if ENERGI-F705 Tablets work to treat Parkinson's disease.
Participants will:
- Take the study drugs twice a day for 72 weeks in the treatment group
- Take routine use of standard-of-care antiparkinsonian medications throughout the study
- Visit the outpatient department at scheduled visits, ranging from Day 1 to approximately every 1 to 4 weeks thereafter, for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose ENERGI-F705 Tablets | Experimental | Drug: 60 milligrams of ENERGI-F705 Tablets60 milligrams of ENERGI-F705 Tablets |
| High-dose ENERGI-F705 Tablets | Experimental | Drug: 120 milligrams of ENERGI-F705 Tablets120 milligrams of ENERGI-F705 Tablets |
| Placebo tablets | Placebo comparator | Drug: Placebo tabletsPlacebo tablets |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit)
- Has been diagnosed with idiopathic Parkinson's disease (defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's disease) for ≥ 2 years prior to or at Visit 2 (Day 1)
- Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit)
- With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit)
- Without motor complications, which is defined as a score of 2 or less on the MDS-UPDRS Part IV score at Visit 1 (Screening Visit)
Key exclusion criteria (33 listed)
- Any subject meeting any of the exclusion criteria will be excluded from study participation:
- Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism
- Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1):
- With Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 (Screening Visit)
- With a lifetime history of significant psychiatric disorder (e.g., alcohol use disorder, drug abuse, or suicide attempt), which in the investigator's opinion, may interfere with study participation
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 |
|---|---|---|
| 60 milligrams of ENERGI-F705 TabletsTablets will be taken orally twice a day | Drug | Low-dose ENERGI-F705 Tablets |
| Placebo tabletsTablets will be taken orally twice a day. | Drug | Placebo tablets |
| 120 milligrams of ENERGI-F705 TabletsTablets will be taken orally twice a day. | Drug | High-dose ENERGI-F705 Tablets |
Primary outcome
Number of participants experiencing adverse events (AE) and serious adverse events (SAE)
Time frame: From Day 1 to Week 76
All AEs and SAEs will be assessed following National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
15 secondary outcomes
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score
Time frame: Baseline to Week 72
MDS-UPDRS Part IV score
Time frame: Baseline to Week 72
Sum of MDS-UPDRS Part I score, MDS-UPDRS Part II score and MDS-UPDRS Part III score
Time frame: Baseline to Week 72
Proportion of participants with 3-point or more increase in MDS-UPDRS Part III score
Time frame: Baseline to Week 72
Time to onset of motor complication
Time frame: From Day 1 to Week 72
Non-motor symptoms scale (NMSS) total score
Time frame: Baseline to Week 72
Parkinson's Disease Questionnaire-39 (PDQ-39) total score
Time frame: Baseline to Week 72
Modified Hoehn and Yahr stage
Time frame: Baseline to Week 72
Levodopa equivalent daily dose (LEDD) of antiparkinsonian medications
Time frame: Baseline to Week 72
Time to the first LEDD adjustment
Time frame: From Day 1 to Week 72
Number of participants with abnormalities in vital signs
Time frame: Baseline to Week 76
Number of participants with abnormalities in laboratory examination results
Time frame: Baseline to Week 76
Number of participants with toxicity grade change for the laboratory examination results
Time frame: Baseline to Week 76
Number of participants with abnormalities in physical examination
Time frame: Baseline to Week 76
Number of participants with transition of electrocardiogram results
Time frame: Baseline to Week 72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Tu-Hsueh YEH, M.D. principal investigator
Department of Neurology, Taipei Medical University Hospital
Chien-Tai Hong, M.D. principal investigator
Department of Neurology, Shuang Ho Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 60 milligrams of ENERGI-F705 Tablets and 120 milligrams of ENERGI-F705 Tablets in people with Parkinson's Disease (PD), run by Energenesis Biomedical Co., Ltd. at 2 sites in Taiwan.
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 21 inclusion and 33 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: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifang Cheng, PhD (+886-2-26270835, ct@energenesis-biomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing adverse events (AE) and serious adverse events (SAE) (time frame: From Day 1 to Week 76). 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 2 Jul 2026.