Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia

Prior treatment

• Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
• The subject has received neurosurgical intervention related to PD or slow-release implants (e.g. deep brain stimulation, thalamotomy, focused ultrasound therapy, continuous levodopa-carbidopa intestinal gel infusion, continuous subcutaneous apomorphine infusion, etc) or is scheduled to do so during the trial period.
• Patients that started to take anti-dyskinetic medication
• Patients taking prohibited medication as provided in Table 7 (Prohibited medications).
• Study participant has been exposed to an investigational drug within 90 days, prior to the first dose of IMP, or is currently participating or planning to participate in another study of an investigational drug.

Other illness

• Unmanaged/uncontrolled comorbidities, including current clinically significant gastro intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, acute gastric/duodenal ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric/duodenal ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
• Neoplastic disorder, which is either currently active or has been in remission for less than one year.
• Patients with severe renal or hepatic impairment.
• The subject has any clinically significant illness that, in the Investigator's opinion, might interfere with the subject's ability to participate in the trial.
• The subject is suffering from any cognitive decline, dementia or other psychiatric illness that prevents him/her from giving informed consent or will not allow the determination of trial outcomes
• Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past three months.

Other

• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
• Female subject that is pregnant or lactating.
• The subject is experiencing exclusively diphasic, off-state, myoclonic, dystonic, or akathitic dyskinesias without peak dose dyskinesia.
• The subject has legal incapacity or limited legal capacity.
• Smoking or vaping products containing nicotine, tobacco or any other products, currently and in the past 1 year.
• Patients that manifested DLTs at any dose level during phase Ia will be excluded from the PK and repeated dose studies (Ib).

• The subject presents with a diagnosis of idiopathic Parkinson's disease
• PD subjects taking stable doses of IR levodopa for at least 4 weeks before Screening Visit
• The dose of levodopa and all PD drugs used during the trial anticipated to remain unchanged throughout the duration of the trial.
• The patient must present symptomatic levodopa induced dyskinesias that is predictable (peak-dose dyskinesia) and is not troublesome, as assessed by the investigator
• The patient did not start taking anti-dyskinetic medication, however, is qualified to start anti-dyskinetic medication based on investigator's assessment
• The subject shows adequate compliance with the schedule of the trial visits, admission in the hospital for the PK study, and the completion of the self-evaluation with Hauser diary.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• In order to understand the nature of this study it is expected that most participants will be able to speak, read, and understand English. However, additional translations of the informed consent may be made available after study initiation to include additional languages for participants
• Study participant must have the capacity and willingness to comply with contraception requirements.
• Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator.
• To be eligible for enrollment in phase Ia and Ib and for each treatment administration in phase Ia, vital signs should be in the following ranges: Heart rate \>50 and \<100 bpm, Systolic pressure \>100 and \<180 mmHg, Diastolic pressure \>50 and \<100 mmHg, Blood oxygenation (by pulse-oximetry) \>95%. If the vitals are outside of the range, they will be reassessed 3 times at 10 minutes resting intervals and the investigator will decide the course of action including reassessment of the vitals, or excluding enrollment.