A Study of LY03003 in Patients With Early-stage Parkinson's Disease
A Study of LY03003 in Patients With Early-stage Parkinson's Disease
This study is to characterize the pharmacokinetics and to evaluate the safety as well as
 tolerability of LY03003 following multiple escalating intramuscular injections
Inclusion Criteria:

 -  Patient had Parkinson's Disease that meet the clinical diagnostic criteria of the
 brain bank of the Parkinson's Disease Association of the United Kingdom.

 -  Patient was Hoehn & Yahr stage ≤3 (excluding stage 0) ;

 -  Patient was male or female aged 18 to 75 years;

 -  Patient had a Mini Mental State Examination (MMSE) score of ≥25;

 -  Patient had a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
 of ≤30 at Screening.

 -  Patient who signed the informed consent form volunteered to participate in this
 clinical trial and could cooperate with the prescribed inspections.

 Exclusion Criteria:

 -  Patient had a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal
 tissue transplant;

 -  Patient had dementia, schizophrenia or hallucinations, or clinically significant
 depression;

 -  Patient had a lifetime history of suicide attempt (including an active attempt,
 interrupted attempt, or aborted attempt), or presence of suicidal tendency in the past
 year;

 -  Patient had a history of orthostatic hypotension.

 -  Patient had received therapy with a dopamine (DA) agonist either concurrently or had
 done so within 28 days prior to the Screening;

 -  Patient had received therapy with 1 of the following drugs either concurrently or
 within 28 days prior to Screening: monoamine oxidase B (MAO-B) inhibitors (e.g.,
 pargyline, selegiline), DA releasing agents (e.g., amphetamine), reserpine,
 DA-antagonists (e.g., metoclopramide), neuroleptics, or other medications that may
 interact with DA function;

 -  Patient was currently (at the time of Screening) receiving central nervous system
 active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the
 dose had been stable for at least 28 days prior to Screening Visit and was likely to
 remain stable for the duration of the study;

 -  Patient had a current diagnosis of epilepsy, had a history of seizures as an adult
 within 1 year prior to Screening, had a history of stroke or transient ischemic attack
 within 3 months prior to Screening;

 -  Patient had a history of known intolerance/hypersensitivity to non-dopaminergic
 antiemetics, such as domperidone, ondansetron, tropisetron;

 -  Patient had any other clinically relevant hepatic, renal, and cardiac dysfunction, or
 laboratory abnormality, which would have, in the judgment of the Investigator,
 interfered with the patient's ability to participate in the study;

 -  Patient had a history of allergic to any medication;

 -  Heavy smoker, alcoholic, drug addict;

 -  Female patients who were pregnant or were breastfeeding or were of childbearing
 potential without adequate contraception;

 -  Patient who was inappropriate to participant in the study in the judgment of the
 Investigator.