| Eligibility |
Inclusion Criteria:
1. Able to read, understand, and provide written consent for the trial, comply with the
clinical trial protocol, and communicate any adverse events (AEs) and other clinically
significant information to the investigator (able to complete the evaluation,
including walking or using walking aids).
2. Adult men and women between the ages of 40 and 75 at Screening.
3. Diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society
(UKPDS) Brain Bank clinical diagnostic criteria and confirmed the reduction of
dopamine transporter on 18F-FP-CIT PET imaging at Screening.
4. Diagnosed with Parkinson's disease within the last 12 months.
5. Modified Hoehn-Yahr stage = 2
6. Eligible females will be:
- females of childbearing potential who are not pregnant, evidenced by a negative
serum hCG pregnancy test at Screening
- non-lactating, or
- surgically sterile (defined as documented bilateral tubal ligation, bilateral
tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal.
- Definition of menopause
- 50 years or over: 12 or more consecutive months without menstruation, in the
absence of other conditions.
- Less than 50 years: FSH level is > 40 IU/L and 12 or more consecutive months
without menstruation, in the absence of other conditions.
Exclusion Criteria:
1. Clinically significant new illness, per Investigator judgment, in the 4 weeks before
Screening and during the screening period.
2. Global Deterioration Scale (GDS) = 4 at Screening.
3. Have clinically significant depression as indicated by a Korean Beck Depression
Inventory II score (K-BDI-II) > 18 at Screening.
4. BMI less than 18 kg/m2 at Screening.
5. Have the following laboratory test results:
- Clinically significant abnormal hepatic (i.e., AST or ALT greater than 2.5x ULN,
or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome)
- Renal function laboratory test (i.e., GFR < 60 mL/min).
6. Have the following medical history:
- Diagnosed with or suspected to have *Parkinson-plus syndromes (PPS)
- PPS: Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal
Degeneration, Diffuse Lewy Body Disease, etc.
- Tremor-dominant Parkinson's disease, per Investigator judgment.
- Symptoms or signs indicative of neurological functional impairment or known
abnormalities in brain CT or MRI imaging.
- A history of severe heart failure (NYHA class III ~ IV), stroke, cerebral
ischemic attacks, or seizures within the past year before screening; or those
with a history of myocardial infarction or unstable angina within the last 6
months before screening.
- Have undergone surgery for Parkinson's disease treatment (e.g., cholecystectomy,
deep brain stimulation, fetal tissue transplantation) or any other major brain
surgery.
- Diagnosed with malignant tumors within the past 5 years before screening, or have
a history of treated neoplasms within the last 3 years before screening (except
for adequately treated basal cell carcinoma, cervical intraepithelial neoplasia,
or flat epithelial atypia).
- Diagnosed with secondary Parkinsonism (drug-induced Parkinsonism, normal pressure
hydrocephalus, vascular Parkinsonism).
7. Have swallowing problems
8. Have clinically significant dizziness, nausea, constipation, per Investigator's
judgment.
9. Currently taking any of the following medications and have the willingness and ability
to continue taking them throughout the clinical trial period:
- Within the 4 weeks before baseline, taking any Parkinson's disease medications,
including dopamine agonists, dopamine-depleting enzyme inhibitors [monoamine
oxidase inhibitors (MAOi), COMT (catechol-O-methyltransferase) inhibitors],
non-dopaminergic drugs (anticholinergic agents, amantadine, etc.), and others PD
medications (In case of irreversible MAO-B inhibitor, within the 90 days before
baseline)
- Within the 12 weeks before screening, have used systemic steroids continuously
for 7 days or longer.
- Currently taking medications known to be substrates of breast cancer resistant
protein (BCRP) at screening (e.g., rosuvastatin, serpalan, etc.) (Note: If
switched to another drug of the same class, the subject may be eligible for
inclusion).
- taking of any medication within 6 months of Screening that can alter reproductive
hormone levels, either as the intended effect or as a side effect, including:
anabolic steroids, androstenedione, bicalutamide, cimetidine,
dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride,
finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and
decadron), oral ketoconazole, megestrol acetate, opiates (e.g., morphine,
codeine, oxycodone, hydrocodone), spironolactone, testosterone or any androgen,
and any medications for treating prostate cancer.
10. A history of taking levodopa or levodopa comination drug.
11. Have known or suspected intolerance to PET scan or fluoropropyl-CIT (18F).
12. Have a history of organ transplantation.
13. Tested positive for HBsAg, HCV Ab, HIV Ag/Ab, or VDRL antibodies in screening tests.
14. Known hypersensitivity or contraindication to the main ingredient and excipients of
the investigational product.
15. Anticipated to undergo surgery during the clinical trial period or to receive surgical
interventions that may affect the completion of the trial or compliance with the
clinical trial protocol.
16. Participated in a clinical trial for an investigational drug or medical device for a
period equal to or longer than five times the drug's half-life at baseline or within
the past 12 weeks, whichever is longer.
17. Unwilling, or whose partner is unwilling, to use a medically acceptable means of
*contraception during and for 90 days following completion/withdrawal of the study.
- Medically acceptable contraceptive methods include:
- intrauterine device that has been proven highly effective, used by the
subject or the subject's spouse/partner
- physical contraception (male or female) used with chemical sterilization
surgical sterilization of the subject or the subject's partner (e.g.,
vasectomy, hysterectomy, tubal ligation, salpingectomy
- oral hormonal contraceptive used by the spouse/partner of male subject.
18. Within the last 2 years before screening or during the screening period, have a
history of alcohol or drug abuse, or have tested positive for drug use during the
screening period (Note: Subjects who have used drugs for the purpose of chronic pain
treatment, have documented records of medical history and concomitant medications,
may, at the investigator's discretion and with the sponsor's approval, be eligible for
inclusion as trial subjects).
19. Deemed unsuitable for participation in the clinical trial by the investigator due to
reasons including clinical laboratory test results and other factors.
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