Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Multiple System Atrophy / Parkinsons Disease
• Age: Between 40 Year(s) - 85 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. A diagnosis of PD or MSA.
  2. Written informed consent is signed and dated by the participant.
  3. 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.
  4. Expected to be able to undergo all study procedures.
  5. Women must be of non-childbearing potential (postmenopausal for at least 12 months prior to screening or surgically sterile) or if of child-bearing potential, must be using medically acceptable contraceptive measures throughout the duration of the study and for at least 24 weeks after their last dose of study treatment.
  6. Male participants and their partners of childbearing potential must commit to the use of medically acceptable contraception for the study duration and for 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 contraception method that is medically acceptable, and these contraceptive measures should be used throughout the duration of the study and for at least 90 days after their last dose of study treatment.
  7. Stable treatment of permitted antiparkinsonian medications from 30 days prior to 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 judgement; except for short-acting rescue medication, which are allowed.
  8. Eligible participants must be fully vaccinated against COVID-19 according to local guidelines. Participants also must have received a COVID-19 booster vaccination.

  
  

You may not be eligible for this study if the following are true:

• 1. Other known or suspected cause of Parkinsonism other than idiopathic PD or MSA, including but not limited to, progressive supranuclear gaze palsy, drug- or toxin-induced parkinsonism, essential tremor, primary dystonia, vascular parkinsonism.
  2. History of Substance Use Disorder within the past 2 years before screening.
  3. Acute or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at Screening or any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, or cytotoxic therapy in the previous 5 years.
  4. History or evidence of an autoimmune disorder (e.g. Sjogren’s syndrome, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis etc.).
  5. History of anergy.
  6. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or vaccine, or multiple drug allergies (non-active hay fever is acceptable).
  7. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) which has not been in remission for at least 5 years prior to Screening.
  8. Contraindication to MRI, including but not limited to the presence of metal devices or implants (e.g., pacemaker, vascular- or heart-valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes.
  9. Receipt of an investigational product or device, or participation in a drug research study within a period of 90 days before baseline.
  10. Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn.
  11. Underwent any procedures/studies involving intracranial surgery, implantation of a device into the brain or stem cell study.
  12. Pregnancy confirmed by a positive pregnancy test.
  13. Participants who are currently breastfeeding or intend to breastfeed during the study. Participants should not be willing to become pregnant and breastfeed until 24 weeks after last injection.
  14. Loss or donation of blood over 500 mL within three months prior to Screening or intention to donate blood or blood products for transfusion during the study and for 13 months after their last dose.
  15. Received blood and/or blood derivatives treatment within 3 months prior to Screening.