Parkinson's Disease (PD)Phase 3NCT07741045
Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsules in Patients With Early-Onset Parkinson's Disease
A Phase 3 study testing TJ0113 200mg and TJ0113 400mg in people with Parkinson's Disease (PD) and Parkinson Disease 6, Early-Onset, run by Hangzhou PhecdaMed Co., Ltd. at 21 sites in China.
Trial summary
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy, safety, and Pop PK characteristics of TJ0113 Capsules in treating EOPD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD), Parkinson Disease 6, Early-Onset
- What is being tested?
- TJ0113 200mg and TJ0113 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 21 sitesChina
- Study dates
- 3 Aug 2026to 15 Nov 2028
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who voluntarily participate in the clinical trial, and have signed the ICF, are able to understand and follow the study protocol, willing to visit the study site on time, fully understand the content, process and potential adverse reactions of the study, and indicate the date of signing the ICF;
- Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF;
- Meets the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria for primary PD[1] or the 2016 Chinese diagnostic criteria for Parkinson's disease[13]; with an age of onset ≤50 years, diagnosed as EOPD;
- Able to cooperate in completing the "off" time records in the diary card;
- Modified Hoehn-Yahr stage 1~2.5 (inclusive) in the "off" state at screening;
- Has been stably receiving anti-PD treatment before baseline and agrees to keep the original anti-PD medication unchanged during the trial; at the time of randomization, the investigator judges that the current treatment regimen has achieved optimal disease management status;
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- "Stably receiving anti-PD treatment" is defined as: 1) Must use levodopa, may be combined with other anti-PD medications; 2) The type and name of anti-PD medications used by the participant have remained unchanged for at least 3 months prior to the baseline visit, and the dose has remained unchanged for at least 1 month prior to the baseline visit; 3) In this trial: No planned dose regimen adjustments during the double-blind treatment period; changes to the dose of stably received anti-PD medications are discouraged during the open-label treatment period, but if necessary, the dose may be adjusted at the discretion of the investigator.
- MDS-UPDRS Part III score ≥22 in off-anti-PD medication state at screening;
- Participants of childbearing potential (including spouses of male participants) who have no childbearing or sperm donation plan from the end of the screening period to within 6 months after the last dose and are willing to use at least one effective method (see Appendix I for details) for contraception.
Who cannot join
- Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: medical history of epilepsy or any complications, medical history of hemolytic anemia, pulmonary embolism, respiratory depression, active psychiatric disease, or malignancy; positive tumor marker detection results at screening and judged by the investigator to be clinically significant;
- Participants who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke, and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair/replacement; or those with severe arrhythmia as judged by the investigator at the time of screening;
- A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF >450 ms (male) or QTcF >470 ms (female) based on resting ECG results at screening;
- Participants with unstably controlled hypertension at screening, defined as the systolic blood pressure ≥ 160 mmHg and/or the diastolic blood pressure ≥ 100 mmHg (verify before randomization);
- Participants with symptomatic orthostatic hypotension at screening, or who experiences a decrease in systolic blood pressure of ≥ 30 mmHg or a decrease in diastolic blood pressure of ≥ 15 mmHg within 3 minutes when changing from the supine to the standing position (verify before randomization);
- Atypical parkinsonian syndromes (such as multiple system atrophy, progressive supranuclear palsy, etc.), or secondary parkinsonism with clearly identified causes such as drug-induced, vascular, toxic, metabolic, infectious, or traumatic brain injury;
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- Participants who have clinically significant hepatic insufficiency which is defined as the total bilirubin (TBIL) > 2 × upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 × ULN;
- Participants with clinically significant renal insufficiency (creatinine clearance [Ccr] <30 mL/min, see Appendix 2 calculation formula);
- Any condition (e.g., severe arthritis, severe dyskinesia, traumatic injury with permanent physical disability) that may affect the MDS-UPDRS motor examination;
- Participants who have a history of suicidal intention (including actual attempts, interrupted attempts, or failed attempts) and are at risk of committing suicide as judged by the investigator;
- Participants judged by the investigator to have severe psychiatric abnormalities (anxiety, depression), with a single item score ≥3 for item 1.3 (Depression) or item 1.4 (Anxiety) in Part 1 of the MDS-UPDRS at screening;
- Participants who have taken any serotonin reuptake inhibitors (such as fluoxetine, paroxetine, trazodone, citalopram, escitalopram, etc.) within 4 weeks prior to screening;
- Use of anticholinergics or amantadine for PD treatment within 3 months prior to screening, or requiring stable use of anticholinergics or amantadine for PD treatment during the trial;
- Participants who have dementia or moderate or above cognitive dysfunction and the MDS-UPDRS score for 1.1 cognitive impairment is ≥ 3 at screening;
- Participants who have a history of surgical treatment for PD (e.g., deep brain stimulation, pallidotomy, etc.), or those who have undergone any major or medium surgery or have experienced any serious trauma or serious infection within 3 months prior to screening, those who are unsuitable for this study at the discretion of the investigator or plan to undergo any surgical treatment (excluding an outpatient surgery that has no impact on participant safety or study results as judged by the investigator) during the study;
- Participants who have participated in a clinical trial that involves the administration of an investigational drug (a new chemical entity), device, or surgery within 3 months or 5 half-lives before screening, whichever is longer;
- Evidence of alcohol abuse (average weekly consumption of ≥14 units of alcohol, where 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine) or drug abuse within 6 months prior to screening, which in the investigator's opinion would interfere with the participant's understanding or completion of the trial;
- Participants who are known to have hypersensitivity/allergic reaction or intolerance to any component of the investigational product;
- Positive for Hepatitis B surface antigen (HBsAg) or positive for Hepatitis B core antibody (HBcAb) with Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) above the upper limit of detection, or positive for Hepatitis C Virus (HCV) antibody, or positive for Human Immunodeficiency Virus (HIV) antibody, or positive for Treponema pallidum antibody at screening;
- Pregnant or breastfeeding women;
- Participants who are unable to swallow oral drugs, or have any condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any condition that may pose a hazard to participants participating in the study, as judged by the investigator;
- Participants who have a history of organ transplantation (excluding corneal transplantation);
- Participants who have donated or lost blood of ≥400 mL, or received blood transfusions within 3 months prior to screening; Participants who have any other conditions that may affect study compliance as deemed by the investigator, or those who are unable to participate in the study for their own reasons.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites
Beijing Hospital
Beijing, Beijing Municipality
Wen Su
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Tao Feng
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Hong Sun
The Third Xiangya Hospital, Central South University
Changsha, Hunan
Lifang Lei
Xiangya Hospital, Central South University
Changsha, Hunan
Jifeng Guo
West China Hospital, Sichuan University
Chengdu, Sichuan
Huifang Shang
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Oumei Cheng
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yuhu Zhang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wen Lv
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
Chenjuan Tao
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wei Luo
Huzhou Central Hospital
Huzhou, Zhejiang
Bing Zhang
Jiaxing Second Hospital
Jiaxing, Zhejiang
Yanping Wang
Lishui Municipal People's Hospital
Lishui, Zhejiang
Xueli Cai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jun Liu
General Hospital of Nuclear Industry (The Second Affiliated Hospital of Soochow University)
Suzhou, Jiangsu
Chengjie Mao
Taizhou Central Hospital
Taizhou, Zhejiang
Lingqun Mao
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Suzhi Liu
Wenzhou Central Hospital
Wenzhou, Zhejiang
Yaxi Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Nian Xiong
Henan Provincial People's Hospital
Zhengzhou, Henan
Jianjun Ma
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsules in Patients With Early-Onset Parkinson's Disease
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy, safety, and Pop PK characteristics of TJ0113 Capsules in treating EOPD patients. This study plans to enroll approximately 300 EOPD participants, who will be randomized in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, successfully screened participants will be stratified by stable use of dopamine receptor agonists (Yes vs. No) and stable use of Monoamine Oxidase B (MAO-B) inhibitors (Yes vs. No), and within each stratum, randomized in a 2:1 ratio to the TJ0113 Capsules group and the placebo group, with approximately 100 assigned to the TJ0113 Capsules group and approximately 50 assigned to the placebo group. In this trial, the sample size for the TJ0113 Capsules 200 mg group, TJ0113 Capsules 400 mg group, and placebo group will each be approximately 100 participants.
After randomization, during the double-blind treatment period, participants will receive continuous oral administration of TJ0113 Capsules or placebo for 26 weeks. After the double-blind treatment ends, participants will enter the open-label treatment period. During the open-label treatment period, all participants will receive oral TJ0113 Capsules for 26 weeks, and the dose of TJ0113 Capsules will be consistent with the dose of the investigational product taken by the participant during the double-blind treatment period (regardless of whether they took TJ0113 Capsules or placebo during the double-blind treatment period). After the open-label treatment period ends, participants will continue to receive a safety follow-up for 1 week (telephone follow-up).
From the screening period to the end of the double-blind treatment period, all participants must maintain their original background anti-PD medication regimen unchanged; from the open-label treatment period to the end of the study, changes to the dose of stably received anti-PD medications are discouraged, but if necessary, the dose may be adjusted at the discretion of the investigator.
- Being tested
- TJ0113 200mg, TJ0113 400mg, Placebo
- Medical subject headings
- Parkinson Disease, Parkinson Disease 6, Autosomal Recessive Early-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ0113 200mgDrug
100 mg Capsule, 2 Capsules Once Daily
TJ0113 400mgDrug
100 mg Capsule, 4 Capsules Once Daily
PlaceboDrug
2 Capsules or 4 Capsules, Once Daily
| Study group | Role | What they receive |
|---|---|---|
| TJ0113 200mg | Experimental | Subjects will receive 100 mg of TJ0113 capsules for 52 consecutive weeks Receives: Drug: TJ0113 200mg |
| TJ0113 400mg | Experimental | Subjects will receive 200 mg of TJ0113 capsules for 52 consecutive weeks Receives: Drug: TJ0113 400mg |
| Placebo | Placebo comparator | Subjects will receive 200mg or 400 mg of placebo for 26 consecutive weeks,and receive 200 mg or 400 mg of TJ0113 capsules for 26 consecutive weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in off-anti-PD medication state at Week 26. "Off-anti-PD medication state" is defined as: ≥12 hours after the last dose of anti-PD medication
Measured: After 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Nov 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741045
- Sponsor's protocol ID
- TJJS01-202
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 12 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsules in Patients With Early-Onset Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07741045
- Acronym / sponsor ID
- TJJS01-202
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 3 Aug 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.
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy, safety, and Pop PK characteristics of TJ0113 Capsules in treating EOPD patients. This study plans to enroll approximately 300 EOPD participants, who will be randomized in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, successfully screened participants will be stratified by stable use of dopamine receptor agonists (Yes vs. No) and stable use of Monoamine Oxidase B (MAO-B) inhibitors (Yes vs. No), and within each stratum, randomized in a 2:1 ratio to the TJ0113 Capsules group and the placebo group, with approximately 100 assigned to the TJ0113 Capsules group and approximately 50 assigned to the placebo group. In this trial, the sample size for the TJ0113 Capsules 200 mg group, TJ0113 Capsules 400 mg group, and placebo group will each be approximately 100 participants.
After randomization, during the double-blind treatment period, participants will receive continuous oral administration of TJ0113 Capsules or placebo for 26 weeks. After the double-blind treatment ends, participants will enter the open-label treatment period. During the open-label treatment period, all participants will receive oral TJ0113 Capsules for 26 weeks, and the dose of TJ0113 Capsules will be consistent with the dose of the investigational product taken by the participant during the double-blind treatment period (regardless of whether they took TJ0113 Capsules or placebo during the double-blind treatment period). After the open-label treatment period ends, participants will continue to receive a safety follow-up for 1 week (telephone follow-up).
From the screening period to the end of the double-blind treatment period, all participants must maintain their original background anti-PD medication regimen unchanged; from the open-label treatment period to the end of the study, changes to the dose of stably received anti-PD medications are discouraged, but if necessary, the dose may be adjusted at the discretion of the investigator.
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 |
|---|---|---|
| TJ0113 200mg | Experimental | Drug: TJ0113 200mgSubjects will receive 100 mg of TJ0113 capsules for 52 consecutive weeks |
| TJ0113 400mg | Experimental | Drug: TJ0113 400mgSubjects will receive 200 mg of TJ0113 capsules for 52 consecutive weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 200mg or 400 mg of placebo for 26 consecutive weeks,and receive 200 mg or 400 mg of TJ0113 capsules for 26 consecutive weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants who voluntarily participate in the clinical trial, and have signed the ICF, are able to understand and follow the study protocol, willing to visit the study site on time, fully understand the content, process and potential adverse reactions of the study, and indicate the date of signing the ICF;
- Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF;
- Meets the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria for primary PD[1] or the 2016 Chinese diagnostic criteria for Parkinson's disease[13]; with an age of onset ≤50 years, diagnosed as EOPD;
- Able to cooperate in completing the "off" time records in the diary card;
- Modified Hoehn-Yahr stage 1~2.5 (inclusive) in the "off" state at screening;
Key exclusion criteria (23 listed)
- Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: medical history of epilepsy or any complications, medical history of hemolytic anemia, pulmonary embolism, respiratory depression, active psychiatric disease, or malignancy; positive tumor marker detection results at screening and judged by the investigator to be clinically significant;
- Participants who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke, and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair/replacement; or those with severe arrhythmia as judged by the investigator at the time of screening;
- A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF >450 ms (male) or QTcF >470 ms (female) based on resting ECG results at screening;
- Participants with unstably controlled hypertension at screening, defined as the systolic blood pressure ≥ 160 mmHg and/or the diastolic blood pressure ≥ 100 mmHg (verify before randomization);
- Participants with symptomatic orthostatic hypotension at screening, or who experiences a decrease in systolic blood pressure of ≥ 30 mmHg or a decrease in diastolic blood pressure of ≥ 15 mmHg within 3 minutes when changing from the supine to the standing position (verify before randomization);
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 |
|---|---|---|
| TJ0113 200mg100 mg Capsule, 2 Capsules Once Daily | Drug | TJ0113 200mg |
| TJ0113 400mg100 mg Capsule, 4 Capsules Once Daily | Drug | TJ0113 400mg |
| Placebo2 Capsules or 4 Capsules, Once Daily | Drug | Placebo |
Primary outcome
Change from baseline in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in off-anti-PD medication state at Week 26. "Off-anti-PD medication state" is defined as: ≥12 hours after the last dose of anti-PD medication
Time frame: After 26 weeks of treatment
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TJ0113 200mg and TJ0113 400mg in people with Parkinson's Disease (PD) and Parkinson Disease 6, Early-Onset, run by Hangzhou PhecdaMed Co., Ltd. at 21 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 9 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: opening soon, as of the sponsor's last update on 12 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 21 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dong Liu (+86-571-88779811, dong.liu@phecdamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in off-anti-PD medication state at Week 26. "Off-anti-PD medication state" is defined as: ≥12 hours after the last dose of anti-PD medication (time frame: After 26 weeks of treatment). 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 12 Aug 2026.