Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease

Trial end date:
Target enrollment:
Participant gender:
The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
Phase 1
Accepts Healthy Volunteers?
Lead Sponsor:
Luye Pharma Group Ltd.
N 0437
Inclusion Criteria:

1. Subject has Idiopathic Parkinson's Disease defined by the cardinal sign, Bradykinesia,
plus the presence of at least 1 of the following: resting tremor, rigidity, or
impairment of postural reflexes, and without any other known or suspected cause of

2. Subject is Hoehn & Yahr stage ≤3

3. Subject is male or female aged ≥18 years at Screening

4. Subject has a Mini Mental State Examination (MMSE) score of ≥25

5. Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
of ≥10 but ≤30 at Screening

Exclusion Criteria:

1. Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., Metoclopramide,
Flunarizine), metabolic neurogenetic disorders (e.g., Wilson's Disease), Encephalitis,
Cerebrovascular Disease, or Degenerative Disease (e.g., progressive Supranuclear

2. Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal
tissue transplant

3. Subject has dementia, active psychosis or hallucinations, or clinically significant

4. Subject has a lifetime history of suicide attempt (including an active attempt,
interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
months as indicated by a positive response ("Yes") to either Question 4 or Question 5
of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening

5. Subject has a history of symptomatic orthostatic hypotension with a decrease of ≥20
mmHg in systolic blood pressure (SBP) or ≥10 mmHg in diastolic blood pressure when
changing from supine to standing position after having been at supine position for at
least 5 minutes within 28 days prior to the Screening Visit, or SBP less than 105 mmHg
at study entry, or reports clinical signs of clinically significant orthostatic
hypotension within 28 days prior to the Screening Visit.

6. Subject is receiving therapy with a dopamine agonist (DA) either concurrently or has
done so within 28 days prior to the Screening

7. Subject is receiving therapy with 1 of the following drugs either concurrently or
within 28 days prior to screening: MAO-B inhibitors, DA releasing agents, DA
modulating agent, DA antagonists, neuroleptics, or other medications that may interact
with DA function.

8. Subject is currently receiving central nervous system active therapy (e.g., sedatives,
hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least
28 days prior to Screening Visit and is likely to remain stable for the duration of
the study. Patients should not take those medications within 8 hours prior to clinical

9. Subject has a current diagnosis of epilepsy, has a history of seizures as an adult,
has a history of stroke, or has had a transient ischemic attack within 1 year prior to

10. Subject has a history of known intolerance/hypersensitivity to non-dopaminergic
antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate

11. Subject has any other clinically relevant hepatic, renal and cardiac dysfunction, or
other medical condition or laboratory abnormality including abnormal plasma magnesium
level, which would in the judgment of the investigator, interfere with the subject's
ability to participate in the study

12. Subject has a history of significant skin hypersensitivity to adhesive or other
transdermal preparations or recent unresolved contact Dermatitis (this item is
specific for patients to be enrolled to part 2 of this study)

13. Subjects with C-reactive protein levels of 2x of upper limit of normal range

14. Female subjects who are pregnant or are breastfeeding or are of childbearing potential
without adequate contraception.

15. Patients with a positive finding in drug screening test or alcohol test