A Phase 1/2a Clinical Study of KL002 in Treatment of Parkinson's Disease

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

40 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

12 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

To assess the safety and tolerability of single doses of KL002 over 78 weeks in subjects with Parkinson's disease。

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Males or females ≥ 40 and ≤ 75 years old
2. Diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
3. Duration of Parkinson's disease motor symptoms: 3-12 years
4. Hoehn and Yahr Stage II-IV (as determined in Practically Defined OFF state)
5. The OFF period MDS-UPDRS III score \> 30 ， and the percent improvement in MDS-UPDRS III in the levodopa/carbidopa challenge test is ≥ 30%
6. Must have been on a stable regimen of Parkinson's disease symptomatic therapy for at least 4 weeks prior to KL002 administration, and must remain stable through dosing unless otherwise approved by the Medical Monitor
7. Must agree to postpone any Parkinson's disease-related neurological surgery, including deep brain stimulation, until after completing the 24-month follow-up
8. Patient has the ability to understand the purpose and risks of the study and provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations

Exclusion Criteria:

1. The diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease that may be a cause for the patient's Parkinson's disease symptoms or may confound study objectives
2. Montreal Cognitive Assessment (MoCA) score of \< 24
3. Hamilton Depression Rating Scale (HAMD) score of \> 17
4. Hypersensitivity or contraindications to corticosteroid use
5. History of previous brain surgery for Parkinson's disease, such as deep brain stimulation or focused ultrasound
6. Clinically significant abnormalities in laboratory test results at screening
7. Atypical Parkinson's disease or secondary Parkinson's disease caused by factors such as chemicals or toxins
8. Use of ambroxol within 8 weeks of dosing
9. Any type of prior gene or cell therapy
10. Contraindications to general anesthesia
11. Any factors that may cause the subject to be unable to follow the study protocol, including medical or social factors, or geographical inconvenience

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Kanglin Biotechnology (Hangzhou) Co., Ltd.

Study start

2026-12 Estimated

Primary completion

2028-08 Estimated

Study completion

2029-10 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts