Intranasal Human FGF-1 for Subjects With Parkinson's Disease

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, pilot study to evaluate the safety, tolerability and efficacy of two dose levels of human FGF-1 administered intranasally to subjects with Parkinson's disease. A low dose of 450 µg FGF-1 (6 µg/kg for a 75 kg subject) and a high dose of 900 µg FGF-1 (12 µg/kg for a 75 kg subject) will be studied sequentially.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhittya Genesis Medicine, Inc.

Criteria

Inclusion Criteria:

1. Males and females 40-80 years of age, inclusive, with a diagnosis of Parkinson's disease. At screening, a further confirmation of the diagnosis of Parkinson's disease will be made by the PI in accordance with accepted medical practices.

2. Female subjects of non-childbearing potential or if of child-bearing potential, on birth control deemed acceptable to the Principal Investigator (PI).

3. Signed and dated informed consent form, which meets all current regulatory criteria.

4. No evidence of proliferative retinopathy or significant non-proliferative retinopathy.

5. Subjects can be on a stable medical therapy for their Parkinson's disease prior to entering the study, as documented by their medical history. Other medications that are acceptable will be at the discretion of the Principal Investigator. At screening it will be stressed that, if possible, subjects should not add, switch or increase doses of any Parkinson's disease medications during the duration of the study.

6. Test drug administration and administration of questionnaires to measure motor function and mental status will be performed in the "on" state.

7. Ability to complete the study in compliance with the protocol in the opinion of the Principal Investigator.

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Exclusion Criteria:

1. Females who are pregnant at screening or of child-bearing potential and not using an acceptable form of birth control.

2. History of allergy or sensitivity to heparin.

3. Significant history or current evidence of chronic infectious disease or other medical conditions that, in the opinion of the Investigator, would compromise the safety of the subject or the study.

4. Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma or squamous cell carcinoma of the skin) will be excluded from the study.

5. Clinically significant ECG abnormalities that in the opinion of the PI could potentially put the patient at risk.

6. Subjects with an HbA1C of >7.5%

7. Uncontrolled hypertension with systolic blood pressure >165 mmHg or diastolic blood pressure >100 mmHg despite diet, exercise or a stable dose of an appropriate antihypertensive therapy for at least 3 months

8. Significant hypotension with systolic blood pressure <85 mmHg or diastolic blood pressure <55 mmHg.

9. Total fasting serum cholesterol >220 mg/dL.

10. A current diagnosis or recent history of psychotic disorder, MDD, bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the Investigator's opinion, would interfere with the subject's ability to participate in the trial.

11. Current use of tobacco products (may have a past history of tobacco use, but not in the last 3 months)

12. Pre-existing retinal disease, including proliferative retinopathy or severe nonproliferative retinopathy

13. Evidence suggesting any type of non-Parkinson disease movement disorder including progressive supranuclear palsy, multiple system atrophy, spinal cerebellar ataxia, etc.

14. Patients who are immunosuppressed.

15. Receipt of any drug as part of a research study within 3 months of the screening visit.

16. History of substance use disorder of moderate to severe severity within 3 months before screening or positive drugs of abuse testing on screening.

17. History of alcohol use disorder of moderate to severe severity within 6 months before screening requiring hospitalization or treatment at an inpatient treatment center.

18. Positive test results for HIV or hepatitis B and C antibodies.

19. Any abnormal laboratory value, condition, medication or medical device that in the opinion of the Principal Investigator could potentially compromise the patient's safety.

20. Unable or unwilling to make the required study visits -