An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination in Individuals Who Have Previously Undergone aSyn Immunotherapy

ConditionParkinson's Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorTridem Bioscience FlexCo

About this trial

An unblinded, single arm, pilot observational study to test the safety, tolerability, immunogenicity and the biological effects of TRB-001 vaccination in individuals who have previously undergone aSyn immunotherapy

Eligibility criteria

Qualifiers

At least 18-years of age

Female or male with previous treatment with active aSyn immunotherapy

Parkinson's disease diagnosis (any stage)

Understands and agrees to comply with the study procedures and provides written informed consent

Disqualifiers

Women of childbearing potential without use of contraception

Women who are pregnant or lactating

Contraindication for MRI or lumbar puncture

Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator

Trial design

Treatments tested in this trial

TRB-001

Treatment groups

6 Participants

are divided into 1 treatment group

Sponsors and collaborators

Tridem Bioscience FlexCo

Lead sponsor

Source ClinicalTrials.gov