Parkinson DiseasePhase 1NCT05493462
Intranasal Human FGF-1 for Subjects With Parkinson's Disease
A Phase 1 study testing Human FGF-1 in people with Parkinson Disease, run by Zhittya Genesis Medicine, Inc. at 1 site in The Bahamas.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Human FGF-1
- How many people
- 4 participants
- Where
- 1 siteThe Bahamas
- Study dates
- Sep 2022to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Female subjects of non-childbearing potential or if of child-bearing potential, on birth control deemed acceptable to the Principal Investigator (PI).
- Signed and dated informed consent form, which meets all current regulatory criteria.
- No evidence of proliferative retinopathy or significant non-proliferative retinopathy.
- 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.
- Test drug administration and administration of questionnaires to measure motor function and mental status will be performed in the "on" state.
- Ability to complete the study in compliance with the protocol in the opinion of the Principal Investigator.
- -
Who cannot join
- Females who are pregnant at screening or of child-bearing potential and not using an acceptable form of birth control.
- History of allergy or sensitivity to heparin.
- 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.
- 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.
- Clinically significant ECG abnormalities that in the opinion of the PI could potentially put the patient at risk.
- Subjects with an HbA1C of >7.5%
Show all 20Show fewer
- 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
- Significant hypotension with systolic blood pressure <85 mmHg or diastolic blood pressure <55 mmHg.
- Total fasting serum cholesterol >220 mg/dL.
- 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.
- Current use of tobacco products (may have a past history of tobacco use, but not in the last 3 months)
- Pre-existing retinal disease, including proliferative retinopathy or severe nonproliferative retinopathy
- Evidence suggesting any type of non-Parkinson disease movement disorder including progressive supranuclear palsy, multiple system atrophy, spinal cerebellar ataxia, etc.
- Patients who are immunosuppressed.
- Receipt of any drug as part of a research study within 3 months of the screening visit.
- History of substance use disorder of moderate to severe severity within 3 months before screening or positive drugs of abuse testing on screening.
- History of alcohol use disorder of moderate to severe severity within 6 months before screening requiring hospitalization or treatment at an inpatient treatment center.
- Positive test results for HIV or hepatitis B and C antibodies.
- Any abnormal laboratory value, condition, medication or medical device that in the opinion of the Principal Investigator could potentially compromise the patient's safety.
- Unable or unwilling to make the required study visits -
Trial locations and contacts
1 site in 1 country.
The Bahamas1 site
The Medical Pavilion Bahamas
Nassau
Conville S Brown, 242-356-6666, drconvillebrown@gmail.com
About this study
Official title: A Clinical Research Study Evaluating the Safety, Tolerability and Efficacy of Intranasally Administered Human FGF-1 in Subjects With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Human FGF-1
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human FGF-1Drug
Intranasal administration of human FGF-1
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Adverse events
Measured: 12 weeks
Secondary outcomes (1)
Efficacy
Motor skill improvement by Parkinson's disease questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhittya Genesis Medicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493462
- Sponsor's protocol ID
- MROS/457920/INDTP
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research Study Evaluating the Safety, Tolerability and Efficacy of Intranasally Administered Human FGF-1 in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05493462
- Acronym / sponsor ID
- MROS/457920/INDTP
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Zhittya Genesis Medicine, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Female subjects of non-childbearing potential or if of child-bearing potential, on birth control deemed acceptable to the Principal Investigator (PI).
- Signed and dated informed consent form, which meets all current regulatory criteria.
- No evidence of proliferative retinopathy or significant non-proliferative retinopathy.
- 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.
Key exclusion criteria (20 listed)
- Females who are pregnant at screening or of child-bearing potential and not using an acceptable form of birth control.
- History of allergy or sensitivity to heparin.
- 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.
- 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.
- Clinically significant ECG abnormalities that in the opinion of the PI could potentially put the patient at risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human FGF-1Intranasal administration of human FGF-1 | Drug | – |
Primary outcome
Safety and tolerability
Time frame: 12 weeks
Adverse events
1 secondary outcome
Efficacy
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human FGF-1 in people with Parkinson Disease, run by Zhittya Genesis Medicine, Inc. at 1 site in The Bahamas.
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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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 The Bahamas. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conville S Brown, MD (242-356-6666, drconvillebrown@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.