UB-312 in Patients With Synucleinopathies

Inclusion criteria

• ✓. Written informed consent is signed and dated by the participant.
• ✓. Male or female aged 40 to 75 years old, inclusive, at screening.
• ✓. Participants must have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
• ✓. Expected to be able to undergo all study procedures.
• ✓. Women must be of non-childbearing potential (postmenopausal for at least 12 months before screening or surgically sterile) or, if of childbearing potential, must be using medically acceptable contraceptive measures throughout the study and for at least 24 weeks after their last dose of study treatment.
• ✓. Male participants and their partners of childbearing potential must commit to using medically acceptable contraception for the study duration and at least 90 days after their last dose of study treatment. Men must refrain from donating sperm during this same period. The female partners should use a medically acceptable contraception method, and these contraceptive measures should be used throughout the study and for at least 90 days after their last dose of study treatment.
• ✓. A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).
• ✓. Stable treatment of permitted antiparkinsonian medications from 30 days before first study drug administration or 60 days for MAO-B inhibitors and expected to remain stable throughout the study unless required adjustment or initiation per the investigator's judgment; except for short-acting rescue medications, which are allowed (see Section 7.1 for the list of permitted medications).

Exclusion criteria