drugset / Trial / NCT05819658

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

NCT05819658

Phase 2 Completed 78 enrolled GemVax & Kael
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP). In 75 patients diagnosed with PSPR Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) at five hospitals in Korea, subcutaneous administration of GV1001 0.56 or 1.12 mg/day will be conducted with multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective phase 2a.

Timeline

Start
2023-06-14
Primary completion
2024-10-11
Completion
2024-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject TERTOMOTIDE Vaccine 0.56 mg Subcutaneous
Subject TERTOMOTIDE Vaccine 1.12 mg Subcutaneous