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Parkinson's DiseasePhase 1/2NCT06480461

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease

A Phase 1/2 study testing VGN-R09b in people with Parkinson's Disease, run by Shanghai Vitalgen BioPharma Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A phase Ⅰ/Ⅱ study to evaluate the tolerability, safety, and efficacy of VGN-R09b in pa-tients with Parkinson's disease Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
VGN-R09b
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
2 Sep 2024to 10 Sep 2030
Phase
Phase 1/2
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

  • Subjects must meet all the following inclusion criteria:
  • Male or female, ≥40 years and <75 years of age at Screening.
  • Diagnosis of Idiopathic Parkinson's disease according to the UK Brain Bank.
  • Insufficient control of motor symptoms with an average of ≥2.5 hours of OFF time per day over 3 consecu-tive days despite optimized treatment, as confirmed by the PD patient diary at Screening.
  • Stable Parkinson's symptoms and an optimal regimen of Parkinson's medications for at least 4 weeks prior to screening, with a duration of levodopa treatment of ≥1 year.
  • Hoehn and Yahr Stage 2.5~4 on "off" state.
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  • All men and women of childbearing potential must be willing to use at least one highly effective method of contraception from the signing of informed consent until one year after administration of the study drug.
  • Men must agree not to donate sperm, and women must agree not to donate eggs within at least one year after administration of the study drug.
  • The patient must understand the purpose and risks of the study, sign and date the informed consent, and give authorization to use the protected health information in accordance with national and local privacy regulations.
  • The patient has a reliable study partner/informant (e.g., a family member, friend) willing and able to partici-pate in the study as a source of information on the patient's health status and cognitive and functional abili-ties (including providing input into the rating scales).

Who cannot join

  • Subject has any of the following diseases or disease history
  • Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, or other neurological disease, or to drugs, chemicals, or tox-ins, as determined by the Investigator.
  • Known pathogenic gene mutations of GBA1, PINK1, and Parkin
  • MoCA score ≤16
  • Currently active infection or a severe infection (e.g., pneumonia, septicemia, central nervous system infec-tions [e.g. meningitis, encephalitis]) within 12 weeks prior to Screening
  • Active infection of HBV, HCV or TP, or with HIV-positive at screening.
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  • Unstable autoimmune disease within 6 months prior to Screening, or requiring chronic immunosuppression.
  • Poorly controlled diabetes (Screening glycosylated hemoglobin [HbA1C] ≥ 7%), or uncontrolled hyperten-sion.
  • History of stroke or transient ischemic attack, unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., un-stable atrial fibrillation) within 1 year prior to Screening.
  • New or unstable psychiatric conditions (e.g. psychosis, severe depression, or with current suicidal ideation or suicide attempt) within 1 year of screening.
  • History of malignancy within 3 years of screening, other than fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated carcinoma in situ, provided it has been stable for at least 6 months.
  • Any medical conditions that, in the opinion of the Investigator, could interfere with study-related proce-dures (including the safe performance of intraparenchymal injection), such as severe dyskinesia/impulse control disorders/tremor that may interfere with drug injection, brain implants, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, or increased intracranial pressure.
  • Subject who is receiving or has a history of any of the following medications
  • Any type of prior gene or cell therapy.
  • Prior brain surgery for deep brain stimulation, focused ultrasound, infusion therapies or any other brain sur-gery for PD, or planned brain surgery for PD within 1 year after study entering.
  • Any anticoagulant or antiplatelet therapies that could not be stopped before study drug injection.
  • Any live vaccine within 4 weeks prior to Screening. Subject who meets any of the following test endpoints at screening
  • An MRI showed a significant structural abnormality or lesion, bleeding, or >1 cm3 infarct, which, in the opinion of the Investigator, are contraindications to intraparenchymal injection.
  • Clinically significant abnormalities in laboratory test values at Screening are in the opinion of the Investiga-tor, unsuitable for enrollment immediately.
  • Subject under any of the following general conditions
  • Contraindications to MRI/PET and/or agents used in PET.
  • Contraindications to general anesthesia or deep sedation.
  • Woman who is pregnant or breastfeeding.
  • Participation within 3 months prior to Screening in another therapeutic investigational drug or device study, unless it can be documented that the patient received a placebo.
  • Presence of substance (drug, alcohol) abuse within 2 years prior to Screening.
  • The patient is generally frail or has any condition for which, in view of the Investigator, participation in the study would not be in the best interest of the patient or is likely to prohibit further participation during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Phase Ⅰb/Ⅱ Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R09b in Patients With Parkinson's Disease

A phase Ⅰ/Ⅱ study to evaluate the tolerability, safety, and efficacy of VGN-R09b in pa-tients with Parkinson's disease

Read the detailed description

In the open-label dose escalation part, 3 dose cohorts will be explored, with 3 subjects per cohort.

Cohort 1: 3 subjects on 8.0×10^11 vg for at least 4 weeks post infusion Cohort 2: 3 subjects on 1.6×10^12 vg for at least 4 weeks post infusion Cohort 3: 3 subjects on 3.2×10^12 vg for at least 4 weeks post infusion In the dose-escalation part, each cohort follows the principle of sentinel administration (i.e., one subject will be enrolled and dosed first in each cohort). If no significant safety risk is observed within 4 weeks after administra-tion, the remaining 2 subjects will be dosed.

Additional cohort(s) and/or a safe low and high dose will be determined by the safety review committee (SRC) to initiate Part II

Being tested
VGN-R09b
Keywords
VGN-R09b
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VGN-R09bDrug

    This is a Phase I/II trial, with safety as the primary measure. Sample size is not determined through statistical justification. There will be 3 subjects in each dose cohort in the dose escalation part. In the dose expansion part, a sham surgery group and 2 dose groups will be designed; 10 subjects will be enrolled in each group.

Study groups in NCT06480461
Study groupRoleWhat they receive
8.0×10^11 vgExperimental3 subjects on 8.0×10^11 vg for at least 4 weeks post infusion
Receives: Drug: VGN-R09b
1.6×10^12 vgExperimental3 subjects on 1.6×1012 vg for at least 4 weeks post infusion
Receives: Drug: VGN-R09b
3.2×10^12 vgExperimental3 subjects on 3.2×1012 vg for at least 4 weeks post infusion
Receives: Drug: VGN-R09b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events (AEs), Serious Adverse Events (SAEs)Vital signs

    Vital signs, physical examination, laboratory test will be monitored after drug injection

    Measured: up to Week 52

Secondary outcomes (3)

  1. Changes in clinical outcomes

    Subject number of MDS-Unified Parkinson's Disease Rating Scale Part I, II, III, and IV (UPDRS III) scores in ON- and OFF state；

    Measured: up to Week 52

  2. Changes in clinical outcomes

    Subject number of Levodopa equivalent daily dose (LEDD)；

    Measured: up to Week 52

  3. Immunogenicity after injection

    Subject number with positive antibodies of AAV9/AADC/Glial Cell Line-Derived Neurotrophic Factor (GDNF) in blood would be reported

    Measured: up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2024
  2. Study start2 Sep 2024
  3. Primary completion10 Sep 2026 (estimated)
  4. Study completion10 Sep 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06480461
Sponsor's protocol ID
VGN-R09b-101
Status last verified
Mar 2026
First submitted
14 Jun 2024
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VGN-R09b in people with Parkinson's Disease, run by Shanghai Vitalgen BioPharma 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 10 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Number of Adverse Events (AEs), Serious Adverse Events (SAEs)Vital signs (time frame: up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06480461.

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 31 Mar 2026.

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