The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes

NCT07156773 | Recruiting Phase 2

• 1 other identifier: 2025-Ⅱ-ZXDB-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of XJN010 Nasal Spray in Patients with Parkinson's Disease Experiencing Off Episodes

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• MDS-UPDRS part III score

  MDS - Unified Parkinson's Disease Rating Scale Part III，The minimum score is 0 and the maximum is 4， higher scores mean a worse outcome.

  Day14

Secondary Outcomes (4)

• The proportion of patients whose condition progresses from the "OFF" phase to the "on" phase and remains in the "on" phase state

  Day14

• The duration of the "OFF" period compared to the baseline value

  Day14

• PDQ-39 score

  Day14

• Maximum blood concentration (Cmax)

  0 to 4 hour after administration

Study Arms (2)

XJN010 Nasal Spray

EXPERIMENTAL

The drug used is XJN010 Nasal Spray.

Drug: XJN010 Nasal Spray

XJN010 Nasal Spray blank preparation.

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

XJN010 Nasal Spray DRUG

In the XJN010 Nasal Spray group, subjects will receive XJN010 Nasal Spray，Based on the frequency of the "off" periods experienced by Parkinson's patients.

XJN010 Nasal Spray

Placebo DRUG

In the XJN010 Nasal Spray blank preparation group, subjects will receive XJN010 Nasal Spray blank preparation, Based on the frequency of the "off" periods experienced by Parkinson's patients .

XJN010 Nasal Spray blank preparation.

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 30 to 85 years (inclusive);
• Diagnosed with Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016), with a disease duration of at least 3 years;
• Patients with a Hoehn-Yahr stage rating (during "on" periods) of 1 to 3;
• Demonstrates responsiveness to levodopa (≥30% improvement/decrease in UPDRS-III score (motor examination) from "off" to "on" state following morning administration of routine levodopa dose);
• Patients must have no plans for conception from 2 weeks before the first dose until 1 month after the last dose, no plans to donate sperm, and agree to use highly effective contraception methods;
• Patients are capable of understanding the study requirements, voluntarily provide written informed consent, and are able to complete the study in compliance with the trial protocol.

You may not qualify if:

• Individuals with motor impairments that severely affect their ability to participate in and perform study procedures;
• Those exhibiting dyskinesia that significantly impacts daily functioning;
• Known hypersensitivity/allergic reaction or intolerance to any component of the investigational drug;
• Previous Parkinson's disease (PD) surgery (including but not limited to deep brain stimulation or brain cell transplantation) or planned PD surgery during the trial period;
• History of malignancy within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, or ductal carcinoma in situ of the breast treated with radical surgery;
• History of severe psychiatric disorders within the past year, such as major depression, mania, schizophrenia, or patients with suicidal tendencies;
• Patients deemed unsuitable for intranasal administration by the investigator (e.g., severe rhinitis, nasal deformities, etc.);
• Those currently receiving centrally nervous system-active medications (e.g., sedatives, hypnotics, antidepressants, anxiolytics), except for those who have maintained a stable dose for at least 30 days prior to screening and can remain stable during the study;
• History of orthostatic hypotension or clinically significant hypotension or orthostatic hypotension identified during screening (orthostatic hypotension is defined as a drop in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes of standing from a supine position)
• Any laboratory test during screening meeting the following criteria:
• Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN); or total bilirubin \>2 × ULN; Renal function: Serum creatinine \>178 μmol/L;11. Pregnant or lactating females, or those with a positive pregnancy test during screening;
• History of drug or alcohol abuse within the past year;
• Participation in a clinical trial and use of an investigational drug within 1 month prior to screening or within 5 drug half-lives (whichever is longer);
• Any other condition considered by the investigator to make the patient unsuitable for participation in the trial.

Sponsors & Collaborators

• Guangzhou Novaken Pharm Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

Guangzhou, Guangdong, 511434, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

HuaLiang Liu, Master

CONTACT

+86+13590957282; liuhl@gznovaken.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 3, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data are available 6 months after the primary publication
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (1)