ClinicalTrials.gg
Status unknownNCT05493462Updated Aug 9, 2022

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

A Phase 1 interventional study of Human FGF-1 in Parkinson Disease, sponsored by Zhittya Genesis Medicine, Inc.. Status unknown at 1 site in Bahamas. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-09.

Sponsored by Zhittya Genesis Medicine, Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The primary objectives of this study are to determine the safety, tolerability and efficacy of human fibroblast growth factor 1 (FGF-1) when administered intranasally to four (4) subjects with idiopathic, stage III or IV Parkinson's disease (Hoehn and Yahr staging criteria). This is an open-label, pilot study to study two dose levels of human FGF-1. 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. Subjects will be screened up to 14 days before administration of the investigational drug product (FGF-1). If the subject complies with all inclusion/exclusion criteria, they will be enrolled in the study.

The proposed daily intranasal dosing regimen for the four subjects is as follows:

Week 1: 450 µg FGF-1 Week 2: 450 µg FGF-1 Week 3: No patient dosing, but safety and efficacy testing will be performed. If deemed safe, but a documented improvement in efficacy is not observed, the four subjects will proceed to administration of a higher dose of FGF-1.

Week 4: daily dosing with 900 µg FGF-1 Weeks 5-12: Follow-up weekly visits; no drug dosing; only safety and efficacy testing will be performed.

Prior to delivering the drug, the subject's vital signs will be taken. Following the intranasal delivery of the FGF-1 dose by the ViaNase® Electronic Atomizer (this device, which the U.S. FDA has authorized for use in humans, releases a metered dose of a drug into each nostril of the subject's nose, which then is inhaled by breathing evenly over a 2-minute period). Vital signs will be measured after the two-minute breathing period and then again in 15 minutes and 30 minutes. Following the final dosing period, follow-up visits for safety testing and efficacy evaluations will be given at weekly intervals for the following 7 weeks.

Safety and tolerability will be assessed by evaluating adverse events (AEs) (including a battery of laboratory evaluations, vital signs, physical examination findings, eye exams, and electrocardiograms [ECGs]). Efficacy will be assessed with the U.S. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). This is a validated questionnaire that takes 30 minutes for a trained medical professional to administer to patients and measures the longitudinal progression of Parkinson's disease, including a section on motor skill testing.

Expected outcomes from this study include establishing that human FGF-1 is safe and tolerable when administered intranasally to subjects with Parkinson's disease and that a clinical benefit is observed in these patients, who currently have very limited medical options.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 4 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Zhittya Genesis Medicine, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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- or if of child-bearing potential, on deemed acceptable to the Principal Investigator (PI).
  3. Signed and dated 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.

Exclusion criteria

-

Exclusion Criteria:

  1. Females who are pregnant at screening or of and not using an acceptable form of .
  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 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. abnormalities that in the opinion of the PI could potentially put the patient at risk.
  6. Subjects with an 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 .
  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 or 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 -
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Interventions

  • DrugHuman FGF-1

    Intranasal administration of human FGF-1

06

What researchers measure

Primary outcomes

  1. Safety and tolerability

    Adverse events

    Time frame: 12 weeks

Secondary outcomes

  1. Efficacy

    Motor skill improvement by Parkinson's disease questionnaire

    Time frame: 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05493462
Lead sponsor
Zhittya Genesis Medicine, Inc.
Responsible party
Sponsor
First posted
Aug 9, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Aug 9, 2022

Study contacts

Conville S Brown, MD
Contact
drconvillebrown@gmail.com
242-356-6666

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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