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RECRUITING
NCT07777484
PHASE1

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

Sponsor: Tridem Bioscience FlexCo

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-07-28

Completion Date

2027-07

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

TRB-001

This is 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. After the screening period, all participants who are enrolled in the study will receive a first intradermal TRB-001 immunization at a dose of 100μg. Patients antibody response will be assessed at week two (compared to baseline). Based on the safety and immunogenicity results, the PI, Medical Monitor, and Sponsor will decide on a potential second immunization with TRB-001. Regarding immunogenicity, a predefined cut-off will be used. The patient may be offered another injection to be applied 4-6 weeks after the first immunization with TRB-001. Participants will be evaluated at week 24. Assessments will include safety, immunogenicity, blood-/CS

Locations (1)

PROSENEX Study Centre at the ATOMOS Klinik Währing

Vienna, Austria